Nausea and Vomiting, Postoperative, Quality of Recovery, Same Day Surgery, Vaginal Prolapse
Conditions
Keywords
Quality of Recovery, Dexamethasone, Same day surgery
Brief summary
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
Detailed description
The lifetime risk of undergoing surgical intervention for pelvic organ prolapse (POP) is estimated to be 10% and it is projected that from 2010 to 2050, the number of surgeries for POP will rise by 47.2%, from 166,000 to 245,970. In 1980, accounting for the rising costs of health care, congress approved Medicare to reimburse procedures performed at outpatient and ambulatory surgery centers. This led to an increasing number of stress incontinence (SUI) procedures being performed in the ambulatory setting from 34,968 in 1996 to 105,656 in 2006. However, the number of ambulatory POP surgeries decreased in the same time period. This was possibly due to the increase in the mean age of women undergoing ambulatory procedures for POP and SUI during that time periods. At the investigator's institution has performed outpatient surgeries for POP and SUI for the past 3 years. Patients have tolerated same day surgery with minimal complications. In the investigator's previous prospective study assessing satisfaction after outpatient surgeries for POP and SUI, patients had a decreased quality of recovery at 48 hours compared to baseline. The investigators also recognized that nausea and pain control could have been better addressed. Unpleasant postoperative nausea and vomiting, pain control, return to normal voiding and return of bowel function can influence the quality of recovery (QOR) from surgery. Postoperative nausea and vomiting (PONV) and pain management are particularly troubling for the patients. This might also delay discharge and prolong convalescence from the surgery. Several safe interventions have been assessed in the literature for alleviating PONV, pain and recovery from laparoscopic gynecologic surgery. Dexamethasone is a potent corticosteroid that has been widely used for chemotherapy induced nausea and vomiting. The mechanism of action is not completely understood. It has been proposed that a single dose may hamper the production and release of anti-inflammatory mediators, thereby decreasing postoperative nausea, emesis, pain perception and Dexamethasone also has a central antiemetic effect by inhibition of prostaglandin and/or release of endogenous opioids. A recent metanalysis concluded that Dexamethasone administration at induction is safe. Pauls et al in their recent study randomized patients undergoing vaginal prolapse surgery to receive Dexamethasone and noted a decrease in PONV and reduced requirement of a rescue antiemetic. Their model involved patients with overnight stay and the results may not be applicable to our population. They also noted that women who received Dexamethasone preoperatively were more likely to pass the voiding trial.
Interventions
DRUGDexamethasone
Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
DRUGNormal saline
Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women over the age of 18 2. Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy 3. ASA class 1-2
Exclusion criteria
1. Daily use of steroids, antiemetics in the month prior to surgery 2. Chronic pain requiring daily opioid treatment 3. History of allergy/intolerance to Dexamethasone 4. ASA class 3 5. Numerical Pain score of more than 4 at baseline 6. Renal/Liver disease 7. Diabetes mellitus 8. Pregnancy 9. Inability to answer questionnaires 10. Any systemic infections 11. Immuno compromised status 12. Patients with planned overnight stay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire: Quality of Recovery 40 | 24 hours | The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Tract Infections | until 6 weeks | Number of UTIs diagnosed in each group |
| Readmissions | 6 weeks | Any patient that is re-admitted to the hospital and the reason for re-admission will be collected. |
| Pain Level | 24 hours | numerical pain scale ranges from 0 to 10, where lower scores represent less pain. |
| Nausea, Vomiting | 24 hrs | Clinically important nausea \>50 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Patients in the Dexamethasone arm will be administered the drug at the time of induction.
Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction. | 24 |
| Normal Saline The placebo arm patients will receive normal saline at the time of induction.
Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction. | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Continuous | 66 years | 65 years | 65 years |
| Body Mass Index | 26 kg/m2 | 28 kg/m2 | 27 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 22 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 24 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Questionnaire: Quality of Recovery 40
The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone | Questionnaire: Quality of Recovery 40 | 174 score on a scale | Standard Deviation 14.49 |
| Normal Saline | Questionnaire: Quality of Recovery 40 | 167 score on a scale | Standard Deviation 16.02 |
Secondary
Nausea, Vomiting
Clinically important nausea \>50
Time frame: 24 hrs
Population: patients with \>50 on nausea scale
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Nausea, Vomiting | 2 participants |
| Normal Saline | Nausea, Vomiting | 2 participants |
Secondary
Pain Level
numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
Time frame: 24 hours
Population: Pain score from 0-10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone | Pain Level | 6.04 score on a scale | Standard Deviation 2.8 |
| Normal Saline | Pain Level | 4.77 score on a scale | Standard Deviation 2.59 |
Secondary
Readmissions
Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
Time frame: 6 weeks
Population: Number or ER visits post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Readmissions | 4 participants |
| Normal Saline | Readmissions | 1 participants |
Secondary
Urinary Tract Infections
Number of UTIs diagnosed in each group
Time frame: until 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Urinary Tract Infections | 1 participants |
| Normal Saline | Urinary Tract Infections | 2 participants |