Opioid Free Anesthesia in Maxillofacial Surgery

Not Applicable

Completed

• Conditions: Maxillofacial Surgery
• Interventions: Other: opioid free anesthesia

• Registration Number: NCT05031676
• Lead Sponsor: Université NAZI BONI

Brief Summary

Opioid free anesthesia is a promising practice in anesthesia. Studies already carried out have compared OFA to an opioid or "opioid anesthesia" (OA) protocol without the use of antihyperalgesic in the OA protocol. Most of the studies currently available have been carried out in Europe, America and a few in Asia under conditions other than those available in precarious situations.That's why we decide to conduct a study to evaluate the effectiveness of an OFA protocol in maxillofacial surgery in Burkina Faso.

Detailed Description

The patients were recruited at the University Hospital of Souro Sanou in Bobo Dioulasso

Study Timeline

• Study Start: 2019-02-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-10-05
• Status Verified: 2021-08
• Study First Submitted: 2021-08-07
• Study First Submitted QC: 2021-08-28
• Last Update Submitted: 2021-08-28
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• All patients aged between 15 and 65 years, admitted to the central operating room of the hospital for maxillofacial surgery.

Exclusion Criteria

• Known or suspected coronary artery disease on preoperative consultation;
• Unstable arterial hypertension
• Insulin-dependent diabetes
• Second degree atrioventricular block
• Neuro-vegetative dysautonomia;
• known allergy or intolerance to a drug of the protocols

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	opioid free anesthesia	Intervention consists at induction : direct intravenous lidocaine 1.5 mg/kg; clonidine 2 μg/kg in 250 ml of isotonic saline, started as soon as the venous route is taken and over a period of approximately 15 minutes; magnesium sulfate 50 mg/kg in the same isotonic saline as clonidine.

Primary Outcome Measures

Name	Time	Method
Highest numerical pain score	First two hours postoperatively	The main highest numerical pain score postoperatively

Secondary Outcome Measures

Name	Time	Method
Wake up	Time between the end of surgery and extubation	wake up time
Nausea-Vomiting	During 24 after surgery	The proportion of nausea-vomiting after surgery
Highest numerical pain score 24 hours	The first 24 hours postoperatively	The mean of the highest EN score during the first 24 hours postoperatively
Heart rate	six minutes after incision	Changes in heart rate
Blood pressure	six minutes after incision	Changes in blood pressure
Ephedrine	During anesthesia	Intraoperative consumption of ephedrine
Non-surgical complications	During 24 hours after surgery	The proportion of non-surgical complications within 24 hours of anesthesia

Trial Locations

Locations (1)

Guibla; 🇧🇫 Bobo-Dioulasso, Houet, Burkina Faso