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
Overview
- Phase
- Not Applicable
- Intervention
- Opiod Free Anesthesia
- Conditions
- Opioids
- Sponsor
- University of Yaounde 1
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Intraoperative variables
- Last Updated
- 5 years ago
Overview
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.
Investigators
Joel Noutakdie Tochie
Medical Doctor/Anesthetist
University of Yaounde 1
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Opiod Free Anesthesia
General anesthesia (GA) group
The GA protocol described in the intervention arm
Intervention: Opiod Free Anesthesia
Outcomes
Primary Outcomes
Intraoperative variables
Time Frame: 9 months
The success rate of OFA (defined as no intraoperative administration of opioids).
Secondary Outcomes
- Postoperative variables(9 months)