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 (OFA-AFRO)

General Anesthesia Usiing Fentanyl Plus Propofol Plus Rococuronium Plus Isoflurane Versus Ketamime Plus Magnesium Sulphate Plus Lidocaine Plus Clonidine Plus Propofol Plus Rococuronium Plus Isoflurane in Gynaecology Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Anesthesia; Clinical Trial; Gynecology; Opioids
• Intervention / Treatment: Drug: Opiod Free Anesthesia

Detailed Description

The investigators intend to conduct a single-blinded randomized controlled trial on American Society of Anesthesiologists (ASA) I and II women who will undergo elective myomectomy, hysterectomy, ovarian cystectomy and mastectomy between June 2021 to September 2021 at the Yaounde Gynaeco-Obstetric and Pediatric Hospital of Cameroon. Participants will be matched for age and parity in a ratio of 1:1 into an Opiod Free Anesthesia (OFA) group and a general anesthesia (GA) group. The primary endpoints shall be the success rate of OFA. The secondary endpoints shall be the mumber or frequency of postoperative complications like respiratory distress, nausea and vomiting, paralitic ileus and severe postoperative pain. The threshold for statistical significance will be set at 0.05.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Noutakdie Tochie, MD; Phone Number: +237 676558825; Email: joeltchie@gmail.com

Study Locations

• Cameroon
  • Centre
    • Yaoundé, Centre, Cameroon, 237
      • Recruiting
      • Yaounde Gynaeco-Obstetric and Pediatric Hospital
      • Contact: Joel Noutakdie Tochie, MD; Phone Number: +237 676558825; Email: joeltochie@gmail.com
      • Contact: Jacqueline Ze Minkande, MD
      • Sub-Investigator: Roddy Stephane Bengono Bengono, MD
      • Sub-Investigator: Junette Arlette Mbengono Metogo, MD
      • Sub-Investigator: Raymond Ndikontar, MD
      • Sub-Investigator: Jacqueline Ze Minkande, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria :

• 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

Exclusion Criteria :

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Opiod Free Anesthesia (OFA) group; 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; 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; Other Names: General anesthesia (GA)
ACTIVE_COMPARATOR: General anesthesia (GA) group; The GA protocol described in the intervention arm	Drug: Opiod Free Anesthesia; 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; Other Names: General anesthesia (GA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative variables	The success rate of OFA (defined as no intraoperative administration of opioids).	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative variables	The number of postoperative complications in the OFA and GA group. The complications to be determined will be the bumber of occurrence of severe postoperative pain, nausea and vomiting, respiratory distress and paralytic ileus	9 months

Collaborators and Investigators

• Sponsor: University of Yaounde 1
• Investigators: Study Director: Jacqueline Ze Minkande, MD, University of Yaounde I

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ANTICIPATED): September 28, 2021
• Study Completion (ANTICIPATED): December 5, 2021

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (ACTUAL): February 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: UY1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No