Phase 4
N=124
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Postoperative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01449708 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: PONV During the First 24 Hours After Bariatric Surgery — 22; 12 participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TIVA NoNarc (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coastal Anesthesiology Consultants
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PONV During the First 24 Hours After Bariatric Surgery |
22; 12 | 0.04 sig |
| SECONDARY Number of Patients Requiring Antiemetic Rescue Medication (AERM) |
26; 17 | — |
| SECONDARY PONV Between Different Surgical Procedures (Percentage of Participants) |
58.6; 19.4; 0; 23.1; 0 | 0.009 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01449708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.