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

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: TIVA NoNarc

• Registration Number: NCT01449708
• Lead Sponsor: Coastal Anesthesiology Consultants

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

Study Timeline

• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Study Start: 2011-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2015-02-27
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-19
• Last Update Submitted: 2016-02-19
• Results First Posted: 2016-03-21
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NoNarc TIVA	TIVA NoNarc	Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine

Primary Outcome Measures

Name	Time	Method
PONV During the First 24 Hours After Bariatric Surgery	24 hours	Postoperative Nausea and Vomiting

Secondary Outcome Measures

Name	Time	Method
Number of Patients Requiring Antiemetic Rescue Medication (AERM)	24hours
PONV Between Different Surgical Procedures (Percentage of Participants)	24 hours

Trial Locations

Locations (1)

Flagler Hospital; 🇺🇸 St. Augustine, Florida, United States