Post-operative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy
Conditions
Keywords
Bariatric Procedure
Brief summary
Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.
Detailed description
To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life. The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.
Interventions
DRUGAprepitant 80 mg Oral Capsule
aprepitant 80 mg orally one hour prior to scheduled surgery
DRUGscopolamine transdermal
scopolamine transdermal patch one hour prior to scheduled surgery
PROCEDURETotal intravenous anesthesia
Maintenance of anesthesia without the use of inhaled anesthetics.
DRUGDexamethasone
Dexamethasone 8 mg intraoperatively
DRUGOndansetron
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
DRUGReglan
Postoperatively scheduled Reglan
DRUGCompazine
Postoperatively as needed compazine for breakthrough PONV
DRUGSugammadex
Reversal with sugammadex
DRUGPropofol
Intravenous anesthesia will be maintained through IV propofol
DRUGdexmedetomidine
maintenance of anesthesia in the intervention arm
DRUGFentanyl
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
DRUGSevoflurane
inhalational anesthesia
DRUGDesflurane
inhalational anesthesia
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients (18 years and older) undergoing LSG
Exclusion criteria
* Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents) * Inability to provide informed consent * History of chronic nausea and emesis requiring medication * Poorly controlled diabetes (HgA1c\>9 mg/dl), * History of previous bariatric or gastro-esophageal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PONV-related Delay of Hospital Discharge | up to 1 week post-operation (up to 2 weeks from baseline) | The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of PONV Measured Using a 10-point Verbal Rating Scale. | Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks | The severity of PONV will be measured using a visual analogue scale. \[0-10\] The higher the value, the worse the outcome. |
| Severity of PONV Measured Using the Rhodes Index | Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks | The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points . The scoring of each item on the Rhodes Index is as follows: 0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named experience, occurrence, and distress . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea . |
| Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey | 24 hours and 3 weeks | The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome. |
| GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey | Baseline, 24 hours and 3 weeks | The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life. |
| Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline, 24 hours and 3 weeks | EQ-5D Descriptive System: Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Levels: Each dimension has 5 severity levels: 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. Extreme problems Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. | 41 |
| Control Arm A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. | 42 |
| Total | 83 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 9.7 | 43 years STANDARD_DEVIATION 13 | 42.2 years STANDARD_DEVIATION 11.4 |
| BMI | 47.3 kg/m2 STANDARD_DEVIATION 6.4 | 46.4 kg/m2 STANDARD_DEVIATION 7.5 | 46.8 kg/m2 STANDARD_DEVIATION 6.9 |
| Previous history of postoperative nausea and vomiting (PONV) | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) White | 29 Participants | 33 Participants | 62 Participants |
| Sex: Female, Male Female | 26 Participants | 29 Participants | 55 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 28 Participants |
| Weight | 292 lbs STANDARD_DEVIATION 52 | 293 lbs STANDARD_DEVIATION 61 | 292.5 lbs STANDARD_DEVIATION 56.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 0 / 41 | 0 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 |
Outcome results
Primary
Number of Participants With PONV-related Delay of Hospital Discharge
The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
Time frame: up to 1 week post-operation (up to 2 weeks from baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Participants With PONV-related Delay of Hospital Discharge | 0 Participants |
| Control Arm | Number of Participants With PONV-related Delay of Hospital Discharge | 4 Participants |
Secondary
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Time frame: Baseline, 24 hours and 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey | Baseline | 108.34 score on a scale | Standard Deviation 12.49 |
| Intervention Arm | GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey | 3 Weeks | 100.71 score on a scale | Standard Deviation 20.6 |
| Control Arm | GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey | Baseline | 107.52 score on a scale | Standard Deviation 13.35 |
| Control Arm | GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey | 3 Weeks | 98.03 score on a scale | Standard Deviation 25.22 |
Secondary
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
EQ-5D Descriptive System: Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Levels: Each dimension has 5 severity levels: 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. Extreme problems Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
Time frame: Baseline, 24 hours and 3 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | None | 29 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Moderate | 4 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | None | 36 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | None | 24 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Moderate | 4 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Slight | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Moderate | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Severe | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | None | 29 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Slight | 3 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | None | 25 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Not Reported | 9 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Moderate | 4 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | None | 37 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | None | 33 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Slight | 6 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Not Reported | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Slight | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Slight | 7 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Moderate | 3 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Severe | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Not Reported | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | None | 26 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Slight | 11 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Not Reported | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Slight | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Moderate | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Severe | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Not Reported | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Slight | 12 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Unable | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Not Reported | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | None | 37 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Not Reported | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | None | 11 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Slight | 13 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Moderate | 5 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Severe | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Unable | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Not Reported | 9 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Moderate | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Not Reported | 9 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Slight | 6 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Moderate | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Not Reported | 9 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | None | 4 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Slight | 16 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Moderate | 12 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | None | 22 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Slight | 5 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Unable | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Not Reported | 9 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Slight | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Moderate | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Severe | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Not Reported | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Moderate | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Not Reported | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | None | 37 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Slight | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Moderate | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Not Reported | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | None | 23 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Slight | 14 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Moderate | 2 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Severe | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Unable | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | None | 38 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Moderate | 1 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Unable | 0 Participants |
| Intervention Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Not Reported | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Severe | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | None | 15 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | None | 25 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Slight | 9 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Severe | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Slight | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Moderate | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Slight | 8 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Severe | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Not Reported | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Severe | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Moderate | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Unable | 5 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Not Reported | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Not Reported | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | None | 25 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Usual activities | Not Reported | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Slight | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Moderate | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Not Reported | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Severe | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | None | 27 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Unable | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Severe | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Slight | 4 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Not Reported | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Not Reported | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Anxiety/depression | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Moderate | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Usual activities | Not Reported | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | None | 28 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Slight | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Moderate | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Slight | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Not Reported | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Moderate | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Not Reported | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | None | 16 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Severe | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | None | 31 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Severe | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Moderate | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Slight | 13 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | None | 29 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Severe | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Slight | 8 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Mobility | Not Reported | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Moderate | 5 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Anxiety/depression | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Severe | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | None | 4 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Usual activities | Not Reported | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Slight | 4 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | None | 29 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Slight | 16 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Slight | 10 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Moderate | 2 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Pain/discomfort | Moderate | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Moderate | 14 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Anxiety/depression | Not Reported | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | None | 29 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Severe | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | None | 27 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Moderate | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Severe | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Pain/discomfort | Not Reported | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Mobility | Not Reported | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | None | 20 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | None | 26 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Slight | 13 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Moderate | 6 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Slight | 7 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Moderate | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Pain/discomfort | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Self-care | Severe | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Severe | 2 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | None | 38 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Slight | 3 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Severe | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 3 weeks: Mobility | Moderate | 1 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | Baseline: Self-care | Unable | 0 Participants |
| Control Arm | Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument | 24 h: Self-care | Unable | 0 Participants |
Secondary
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.
Time frame: 24 hours and 3 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Arm | Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey | 24 hr | 120.59 score on a scale |
| Intervention Arm | Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey | 3 weeks | 137.53 score on a scale |
| Control Arm | Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey | 3 weeks | 130.64 score on a scale |
| Control Arm | Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey | 24 hr | 109.29 score on a scale |
Secondary
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
The severity of PONV will be measured using a visual analogue scale. \[0-10\] The higher the value, the worse the outcome.
Time frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 1 hr | 2.29 score on a scale | Standard Deviation 2.86 |
| Intervention Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 4 hr | 1.46 score on a scale | Standard Deviation 1.82 |
| Intervention Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 12 hr | 0.69 score on a scale | Standard Deviation 1.47 |
| Intervention Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | Baseline | 0.12 score on a scale | Standard Deviation 0.56 |
| Intervention Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 3 week | 0.15 score on a scale | Standard Deviation 0.43 |
| Intervention Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 24 hr | 0.44 score on a scale | Standard Deviation 1.16 |
| Control Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 3 week | 0.58 score on a scale | Standard Deviation 1.68 |
| Control Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 24 hr | 1.80 score on a scale | Standard Deviation 2.89 |
| Control Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | Baseline | 0.10 score on a scale | Standard Deviation 0.43 |
| Control Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 4 hr | 2.76 score on a scale | Standard Deviation 2.97 |
| Control Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 12 hr | 2.19 score on a scale | Standard Deviation 2.63 |
| Control Arm | Severity of PONV Measured Using a 10-point Verbal Rating Scale. | 1 hr | 3.68 score on a scale | Standard Deviation 3.45 |
Secondary
Severity of PONV Measured Using the Rhodes Index
The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points . The scoring of each item on the Rhodes Index is as follows: 0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named experience, occurrence, and distress . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .
Time frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Arm | Severity of PONV Measured Using the Rhodes Index | Baseline | 0.08 score on a scale |
| Intervention Arm | Severity of PONV Measured Using the Rhodes Index | 12 hr | 1.79 score on a scale |
| Intervention Arm | Severity of PONV Measured Using the Rhodes Index | 24 hr | 0.69 score on a scale |
| Intervention Arm | Severity of PONV Measured Using the Rhodes Index | 3 weeks | 0.13 score on a scale |
| Control Arm | Severity of PONV Measured Using the Rhodes Index | 3 weeks | 1.42 score on a scale |
| Control Arm | Severity of PONV Measured Using the Rhodes Index | Baseline | 0.19 score on a scale |
| Control Arm | Severity of PONV Measured Using the Rhodes Index | 24 hr | 5.26 score on a scale |
| Control Arm | Severity of PONV Measured Using the Rhodes Index | 12 hr | 6.17 score on a scale |