TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

Phase 2

Completed

• Conditions: Obesity; Desflurane; Pain, Postoperative; Nausea, Postoperative; Total Intravenous Anesthesia
• Interventions: Drug: Desflurane

• Registration Number: NCT03727607
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

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 \[18\].

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-30
• Primary Completion: 2017-12-11
• Study Completion: 2018-03-14
• Study First Submitted: 2018-03-14
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Study First Posted: 2018-11-01
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gass	Desflurane	DESFLURANE ANESTHESIA
TIVA	Desflurane	TOTAL INTRAVENOUS ANESTHESIA

Primary Outcome Measures

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