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)

University of Yaounde 1

Status: Unknown

Conditions: Surgery; Clinical Trial; Opioids; Gynecology; Anesthesia

Treatments: Drug: Opiod Free Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04737473

UY1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Opiod Free Anesthesia (OFA) group

Experimental group

Description:

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.

Treatment:

Drug: Opiod Free Anesthesia

General anesthesia (GA) group

Active Comparator group

Description:

The GA protocol described in the intervention arm

Treatment:

Drug: Opiod Free Anesthesia