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

NCT ID: NCT04737473

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2021-12-05

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.

Conditions

Opioids; Clinical Trial; Anesthesia; Gynecology; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Opiod Free Anesthesia

Intervention Type: DRUG

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

General anesthesia (GA) group

The GA protocol described in the intervention arm

Group Type: ACTIVE_COMPARATOR

Opiod Free Anesthesia

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

General anesthesia (GA)

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Yaounde 1

OTHER

Sponsor Role: lead

Responsible Party

Joel Noutakdie Tochie

Medical Doctor/Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacqueline Ze Minkande, MD

Role: STUDY_DIRECTOR

University of Yaounde I

Locations

Yaounde Gynaeco-Obstetric and Pediatric Hospital

Yaoundé, Centre Region, Cameroon

Site Status: RECRUITING

Countries

Cameroon

Central Contacts

Joel Noutakdie Tochie, MD

Role: CONTACT

joeltchie@gmail.com

+237 676558825

Facility Contacts

Joel Noutakdie Tochie, MD

Role: primary

joeltochie@gmail.com

+237 676558825

Jacqueline Ze Minkande, MD

Role: backup

References

Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.

Reference Type: RESULT

PMID: 31366330 (View on PubMed)

Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.

Reference Type: RESULT

PMID: 30802933 (View on PubMed)

Tochie JN, Bengono Bengono RS, Metogo JM, Ndikontar R, Ngouatna S, Ntock FN, Minkande JZ. The efficacy and safety of an adapted opioid-free anesthesia regimen versus conventional general anesthesia in gynecological surgery for low-resource settings: a randomized pilot study. BMC Anesthesiol. 2022 Oct 24;22(1):325. doi: 10.1186/s12871-022-01856-6.

Reference Type: DERIVED

PMID: 36280804 (View on PubMed)

Other Identifiers

UY1

Identifier Type: -

Identifier Source: org_study_id