OFA-AFRO: 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

• Sponsor: University of Yaounde 1 (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04737473
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioids; Clinical Trial; Anesthesia; Gynecology; Surgery	Drug: Opiod Free Anesthesia	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 6, 2020
• Anticipated Primary Completion Date: Sep 28, 2021
• Anticipated Study Completion Date: Dec 5, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Intraoperative variables [9 months]

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

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yaounde Gynaeco-Obstetric and Pediatric Hospital	Yaoundé	Centre	Cameroon	237

Sponsors and Collaborators

• University of Yaounde 1

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel Noutakdie Tochie, Medical Doctor/Anesthetist, University of Yaounde 1
• ClinicalTrials.gov Identifier: NCT04737473
• Other Study ID Numbers: UY1
• First Posted: Feb 3, 2021
• Last Update Posted: Feb 3, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Feb 3, 2021