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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449708
• Other study ID #: 3766 - 6886
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2011
• Last updated: February 24, 2014
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Coastal Anesthesiology Consultants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• TIVA NoNarc
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

Locations

Country	Name	City	State
United States	Flagler Hospital	St. Augustine	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Coastal Anesthesiology Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PONV during the first 48 hours after bariatric surgery		48 hours	No
Secondary	Patient satisfaction with perioperative treatment		48 hours	No

External Links

•   Published Results