Anesthesia, Clinical Trial, Gynecology, Opioids, Surgery
Conditions
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.
Interventions
DRUGOpiod 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
Sponsors
University of Yaounde 1
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative variables | 9 months | The success rate of OFA (defined as no intraoperative administration of opioids). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Cameroon
Contacts
Primary ContactJoel Noutakdie Tochie, MD
Outcome results
None listed