The Comparative Efficacy and Safety of Two General Anesthesia Protocols Consisting of Fentanyl Plus Propofol Plus Rococuronium Plus Isoflurane Versus Ketamime Plus Magnesium Sulphate Plus Lidocaine Plus Clonidine Plus Propofol Plus Rococuronium Plus Isoflurane for Gynaecology Surgery in Cameroon

NCT04737473 | Unknown DMC

• 1 other identifier: UY1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, a lot of side effects have been identified from the perioperative use of opioids. To remedy this, anesthesia research has recently focused on providing safe general anesthesia without opioids in a new concept or anesthetic technic called Opiod Free Anesthesia (OFA). Evidence on the effectiveness and safety of OFA is scarce in Africa, with no report from Cameroon.The aim of this study is to demonstrate the feasibility of an adapted OFA protocol as well as its efficacy and safety in very painful surgeries like gynaecology surgery in a low-resource setting.

Conditions

Opioids; Clinical Trial; Anesthesia; Gynecology; Surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative variables

  The success rate of OFA (defined as no intraoperative administration of opioids).

  9 months

Secondary Outcomes (1)

• Postoperative variables

  9 months

Study Arms (2)

Opiod Free Anesthesia (OFA) group

EXPERIMENTAL

The OFA protocol will entailed induction of anesthesia intravenously by the administration of the following drugs: magnesium sulfate 40mg/kg (without exceeding 2.5g), lidocaine 1.5mg/kg, ketamine 25mg, propofol 1.5-2mg/kg, dexamethasone 8mg and rocuronium 0.6mg/kg. Anesthesia will be maintained using isofluorane through volume controlled ventilation, and a mixture of magnesium sulfate 40mg/kg (without exceeding 2.5g/24h), lidocaine 1.5mg/kg, ketamine 25mg, and clonidine 1ug/kg in an electric pump syringe at 10 - 15 ml/h.

Drug: Opiod Free Anesthesia

General anesthesia (GA) group

ACTIVE COMPARATOR

The GA protocol described in the intervention arm

Drug: Opiod Free Anesthesia

Interventions

Opiod Free Anesthesia DRUG

The OFA protocol will entailed induction of anesthesia intravenously by the administration of the following drugs: magnesium sulfate 40mg/kg (without exceeding 2.5g), lidocaine 1.5mg/kg, ketamine 25mg, propofol 1.5-2mg/kg, dexamethasone 8mg and rocuronium

Also known as: General anesthesia (GA)

General anesthesia (GA) group; Opiod Free Anesthesia (OFA) group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Females aged between 21 to 70 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) grade I and II patients
• Patients undergoing an elective myomectomy, hysterectomy, ovarian cystectomy or total mastectomy.
• Patients who will be operated for benign pathologies or localized malignancies

You may not qualify if:

• Past history of allergy to any of the anesthetic drugs
• Refusal to consent to participate in the study

Sponsors & Collaborators

• University of Yaounde 1: lead

Study Sites (1)

Yaounde Gynaeco-Obstetric and Pediatric Hospital

Yaoundé, Centre Region, 237, Cameroon

RECRUITING

Related Publications (3)

• Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.

  PMID: 31366330 RESULT

• Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.

  PMID: 30802933 RESULT

• Tochie JN, Bengono Bengono RS, Metogo JM, Ndikontar R, Ngouatna S, Ntock FN, Minkande JZ. The efficacy and safety of an adapted opioid-free anesthesia regimen versus conventional general anesthesia in gynecological surgery for low-resource settings: a randomized pilot study. BMC Anesthesiol. 2022 Oct 24;22(1):325. doi: 10.1186/s12871-022-01856-6.

  PMID: 36280804 DERIVED

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Jacqueline Ze Minkande, MD

  University of Yaounde I

  STUDY DIRECTOR

Central Study Contacts

Joel Noutakdie Tochie, MD

CONTACT

+237 676558825; joeltchie@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor/Anesthetist

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: February 3, 2021
• Study Start: January 6, 2020
• Primary Completion: September 28, 2021
• Study Completion: December 5, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)