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Completed

NCT Number: NCT03727607

TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

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].

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Desflurane

Drug

Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

Other names: PROPOFOL

Primary outcomes

  1. Awakening time after surgery

    Time frame: 2 hours postdose

    time noted from anaesthesia stoped to patients awake

  2. Degree of nausea and vomiting after surgery

    Time frame: 48 hours postsurgery

    Noted using NRS scale (from 0-10)

  3. Degree of pain after surgery

    Time frame: 48 hours post surgery

    Noted using NRS scale (from 0-10)

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 1, 2018
Registry last updated
Nov 1, 2018

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.

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