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

Not Applicable

• Conditions: Opioids; Anesthesia; Clinical Trial; Gynecology; Surgery
• Interventions: Drug: Opiod Free Anesthesia

• Registration Number: NCT04737473
• Lead Sponsor: University of Yaounde 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.

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 Timeline

• Study Start: 2020-01-06
• Status Verified: 2021-01
• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-31
• Last Update Submitted: 2021-01-31
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-09-28
• Study Completion: 2021-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Opiod Free Anesthesia (OFA) group	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 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.
General anesthesia (GA) group	Opiod Free Anesthesia	The GA protocol described in the intervention arm

Primary Outcome Measures

Name	Time	Method
Intraoperative variables	9 months	The success rate of OFA (defined as no intraoperative administration of opioids).

Secondary Outcome Measures

Name	Time	Method
Postoperative variables	9 months	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

Trial Locations

Locations (1)

Yaounde Gynaeco-Obstetric and Pediatric Hospital; 🇨🇲 Yaoundé, Centre, Cameroon