Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT01449708|
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: TIVA NoNarc||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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
- PONV During the First 24 Hours After Bariatric Surgery [ Time Frame: 24 hours ]Postoperative Nausea and Vomiting
- Number of Patients Requiring Antiemetic Rescue Medication (AERM) [ Time Frame: 24hours ]
- PONV Between Different Surgical Procedures (Percentage of Participants) [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449708
|United States, Florida|
|St. Augustine, Florida, United States, 32086|
|Principal Investigator:||Patrick Ziemann-Gimmel, MD||Coastal Anesthesiology|