Skip to main content
OpenTrials
Completed

NCT Number: NCT01449708

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Flagler Hospital

Saint Augustine, Florida, 32086, United States

About this study

See above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TIVA NoNarc

Drug
  • 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

Primary outcomes

  1. PONV During the First 24 Hours After Bariatric Surgery

    Time frame: 24 hours

    Postoperative Nausea and Vomiting

Secondary outcomes

  1. Number of Patients Requiring Antiemetic Rescue Medication (AERM)

    Time frame: 24hours

  2. PONV Between Different Surgical Procedures (Percentage of Participants)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Coastal Anesthesiology Consultants

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.