Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery|
- PONV During the First 24 Hours After Bariatric Surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Postoperative Nausea and Vomiting
- Number of Patients Requiring Antiemetic Rescue Medication (AERM) [ Time Frame: 24hours ] [ Designated as safety issue: No ]
- PONV Between Different Surgical Procedures (Percentage of Participants) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
No Intervention: Balanced Anesthesia
Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
Active Comparator: NoNarc TIVA
Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine
Drug: TIVA NoNarc
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449708
|United States, Florida|
|St. Augustine, Florida, United States, 32086|
|Principal Investigator:||Patrick Ziemann-Gimmel, MD||Coastal Anesthesiology|