TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

October 31, 2018 updated by: Ostfold Hospital Trust

A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea

Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery.

The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies which have shown a reduction in postoperative nausea and vomiting following TIVA, and there are publications showing no statistically significant difference.

The aim of this study was to investigate the best anaesthetic approach for obese subjects, evaluating awakening time, postoperative nausea and pain.

Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and therefore might have a prolonged effect in obese patients, leading to a longer awakening time along with postoperative nausea and vomiting. This hypothesis is also described earlier by obese patients have more depots (bulk fat) and also more fat surface making anaesthetics storage more easier, and also that the anesthetic will return into the circulation when the administration is stopped [18].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥35 kg/m2 with at least one comorbid condition or BMI ≥40 kg/m2.

Exclusion Criteria:

  • drug abuse
  • severe mental illness
  • age<18
  • serious medical condition; cancer, end-stage lung disease (ASA>3) or allergies to any drugs used in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gass
DESFLURANE ANESTHESIA
Drug: Desflurane
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
Other Names:
  • PROPOFOL
Active Comparator: TIVA
TOTAL INTRAVENOUS ANESTHESIA
Drug: Desflurane
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
Other Names:
  • PROPOFOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awakening time after surgery
Time Frame: 2 hours postdose
time noted from anaesthesia stoped to patients awake
2 hours postdose
Degree of nausea and vomiting after surgery
Time Frame: 48 hours postsurgery
Noted using NRS scale (from 0-10)
48 hours postsurgery
Degree of pain after surgery
Time Frame: 48 hours post surgery
Noted using NRS scale (from 0-10)
48 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostfold Hospital Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2016

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

March 14, 2018

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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