CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
TIVA NoNarcdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01449708
NCT01449708Phase 4Completed

Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery

Coastal Anesthesiology Consultants·interventional·Posted Oct 10, 2011·Updated Mar 21, 2016

In Brief

A Phase 4 clinical trial evaluating TIVA NoNarc for Postoperative Nausea and Vomiting. Completed, enrolled 124 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2011
Enrollment StartNov 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.7 years ago

Interventions

TIVA NoNarcdrug

* 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