Postoperative Nausea and Vomiting
Conditions
Keywords
Bariatric Surgery, TIVA, PONV, non-opioid, OSA
Brief summary
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases. Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication. Our study hypothesis is that different types of anesthetics reduce PONV further. Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA). The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.
Detailed description
See above
Interventions
DRUGTIVA NoNarc
* patients in both groups receive antiemetic prophylaxis * patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively * postop management in both groups is similar in both groups
Sponsors
Coastal Anesthesiology Consultants
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
No
Inclusion criteria
* All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.
Exclusion criteria
* Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PONV During the First 24 Hours After Bariatric Surgery | 24 hours | Postoperative Nausea and Vomiting |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients Requiring Antiemetic Rescue Medication (AERM) | 24hours |
| PONV Between Different Surgical Procedures (Percentage of Participants) | 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Classic/Balanced Anesthesia Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
* patients in both groups receive antiemetic prophylaxis
* postop management in both groups is similar in both groups | 59 |
| TIVA * patients in both groups receive antiemetic prophylaxis
* patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
* postop management in both groups is similar in both groups | 60 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | respiratory failure | 1 | 0 |
| Overall Study | surgical complication | 1 | 2 |
Baseline characteristics
| Characteristic | Classic/Balanced Anesthesia | TIVA | Total |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 3.2 | 50.5 years STANDARD_DEVIATION 3.5 | 50.4 years STANDARD_DEVIATION 2.4 |
| Region of Enrollment United States | 59 participants | 60 participants | 119 participants |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 82 Participants |
| Sex: Female, Male Male | 16 Participants | 21 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
Primary
PONV During the First 24 Hours After Bariatric Surgery
Postoperative Nausea and Vomiting
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic / Balanced Anesthesia | PONV During the First 24 Hours After Bariatric Surgery | 22 participants |
| TIVA | PONV During the First 24 Hours After Bariatric Surgery | 12 participants |
p-value: 0.0495% CI: [1.01, 1.61]Chi-squared
Secondary
Number of Patients Requiring Antiemetic Rescue Medication (AERM)
Time frame: 24hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic / Balanced Anesthesia | Number of Patients Requiring Antiemetic Rescue Medication (AERM) | 26 participants |
| TIVA | Number of Patients Requiring Antiemetic Rescue Medication (AERM) | 17 participants |
Secondary
PONV Between Different Surgical Procedures (Percentage of Participants)
Time frame: 24 hours
Population: analysis was conducted with all participants and NOT per arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Classic / Balanced Anesthesia | PONV Between Different Surgical Procedures (Percentage of Participants) | Sleeve Gastrectomy | 58.6 percentage of participants |
| Classic / Balanced Anesthesia | PONV Between Different Surgical Procedures (Percentage of Participants) | Gastric Bypass (LRYGB) | 19.4 percentage of participants |
| Classic / Balanced Anesthesia | PONV Between Different Surgical Procedures (Percentage of Participants) | Gastric Band | 0 percentage of participants |
| Classic / Balanced Anesthesia | PONV Between Different Surgical Procedures (Percentage of Participants) | revision LRYGB | 23.1 percentage of participants |
| Classic / Balanced Anesthesia | PONV Between Different Surgical Procedures (Percentage of Participants) | Conversion to LRYGB | 0 percentage of participants |
Comparison: Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)p-value: 0.00995% CI: [1.28, 7.29]Chi-squared