Anaesthesia for Laparoscopic Sleeve Gastrectomy

NCT03029715 | Completed Results

• 1 other identifier: MenoufiaU2016/2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. The present study was carried out to compare the use of inhalation anaesthesia technique using desflurane and TIVA using propofol and dexmedetomidine. Methods: This randomized controlled trial was carried out on 100 morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion. Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and post-anaesthetic care unit (PACU) stay were studied for both groups.

Conditions

Obese

Keywords

Sleeve gastrectomy; TIVA

Outcome Measures

Primary Outcomes (1)

• Analgesic Requirements.

  Total paracetamol consumption.

  Within one hour after surgery

Secondary Outcomes (1)

• The Intra-operative Mean Arterial Blood Pressure.

  During operation and follow-up, an average of 2 hours

Study Arms (2)

Intravenous anaesthesia

OTHER

Propofol Dexmedetomidine Remifentanil

Drug: Propofol; Drug: Remifentanil; Drug: Dexmedetomidine

Inhalation anaesthesia

OTHER

Desflurane Remifentanil

Drug: Remifentanil; Drug: Desflurane

Interventions

Propofol DRUG

Total intravenous anaesthesia.

Also known as: TIVA group

Intravenous anaesthesia

Remifentanil DRUG

Narcotics

Also known as: TIVA group and inhalation group

Inhalation anaesthesia; Intravenous anaesthesia

Dexmedetomidine DRUG

Total intravenous anaesthesia

Also known as: TIVA group

Intravenous anaesthesia

Desflurane DRUG

Inhalation anaesthesia.

Also known as: Inhalation group

Inhalation anaesthesia

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Morbid obese scheduled for sleeve gastrectomy.

You may not qualify if:

• Patients refusal and allergy to drugs used.

Sponsors & Collaborators

• Menoufia University: lead

Related Publications (1)

• Elbakry AE, Sultan WE, Ibrahim E. A comparison between inhalational (Desflurane) and total intravenous anaesthesia (Propofol and dexmedetomidine) in improving postoperative recovery for morbidly obese patients undergoing laparoscopic sleeve gastrectomy: A double-blinded randomised controlled trial. J Clin Anesth. 2018 Mar;45:6-11. doi: 10.1016/j.jclinane.2017.12.001. Epub 2017 Dec 8.

  PMID: 29223575 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Propofol; Remifentanil; Dexmedetomidine; Desflurane

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Dr Ezzeldin Ibrahim
• Organization: Menoufia Univeristy

ezzeldin7@yahoo.com

0021006303178

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

• First Submitted: January 14, 2017
• First Posted: January 24, 2017
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share