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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)

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ClinicalTrials.gov Identifier: NCT04737473
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Joel Noutakdie Tochie, University of Yaounde 1

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.

Condition or disease Intervention/treatment Phase
Opioids Clinical Trial Anesthesia Gynecology Surgery Drug: Opiod Free Anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : September 28, 2021
Estimated Study Completion Date : December 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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
Other Name: General anesthesia (GA)

Active Comparator: General anesthesia (GA) group
The GA protocol described in the intervention arm
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
Other Name: General anesthesia (GA)




Primary Outcome Measures :
  1. Intraoperative variables [ Time Frame: 9 months ]
    The success rate of OFA (defined as no intraoperative administration of opioids).


Secondary Outcome Measures :
  1. Postoperative variables [ Time Frame: 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



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females aged between 21 to 70 years old
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737473


Contacts
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Contact: Joel Noutakdie Tochie, MD +237 676558825 joeltchie@gmail.com

Locations
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Cameroon
Yaounde Gynaeco-Obstetric and Pediatric Hospital Recruiting
Yaoundé, Centre, Cameroon, 237
Contact: Joel Noutakdie Tochie, MD    +237 676558825    joeltochie@gmail.com   
Contact: Jacqueline Ze Minkande, MD         
Sub-Investigator: Roddy Stephane Bengono Bengono, MD         
Sub-Investigator: Junette Arlette Mbengono Metogo, MD         
Sub-Investigator: Raymond Ndikontar, MD         
Sub-Investigator: Jacqueline Ze Minkande, MD         
Sponsors and Collaborators
University of Yaounde 1
Investigators
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Study Director: Jacqueline Ze Minkande, MD University of Yaounde I
Publications of Results:
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Responsible Party: Joel Noutakdie Tochie, Medical Doctor/Anesthetist, University of Yaounde 1
ClinicalTrials.gov Identifier: NCT04737473    
Other Study ID Numbers: UY1
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs