TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727607
• Other study ID #: 2016/1659
• Status: Completed
• Phase: Phase 2
• Start date: January 30, 2016
• Est. completion date: March 14, 2018

Study information

• Verified date: October 2018
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 14, 2018
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Desflurane
• Nausea
• Nausea, Postoperative
• Obesity
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Total Intravenous Anesthesia

Intervention

Drug:
• Desflurane
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Outcome

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