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

Surgery Clinical Trial

— OFA-AFRO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737473
• Other study ID #: UY1
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 5, 2021

Study information

• Verified date: January 2021
• Source: University of Yaounde 1
• Contact: Joel Noutakdie Tochie, MD
• Phone: +237 676558825
• Email: joeltchie[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 5, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Clinical Trial
• Gynecology
• Opioids
• Surgery

Intervention

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

Locations

Country	Name	City	State
Cameroon	Yaounde Gynaeco-Obstetric and Pediatric Hospital	Yaoundé	Centre

Sponsors (1)

Lead Sponsor	Collaborator
University of Yaounde 1

Country where clinical trial is conducted

Cameroon, 

References & Publications (2)

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. — View Citation

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 retrosp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative variables	The success rate of OFA (defined as no intraoperative administration of opioids).	9 months
Secondary	Postoperative variables	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	9 months