Opioid Free Anesthesia in Maxillofacial Surgery

Study Overview
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Brief Summary
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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
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The patients were recruited at the University Hospital of Souro Sanou in Bobo Dioulasso

Official Title
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Efficiency of Opioid-free Anesthesia (OFA) in Maxillofacial Surgery

Conditions
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Maxillofacial Surgery

Intervention / Treatment
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* Other: opioid free anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were randomized during the pre-anesthetic visit in two groups 1 and 2. They were randomized in blocks of four so that, in each block of four patients, there were two patients for the protocol 1 and two patients for the protocol 2.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>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. | Other: opioid free anesthesia<br>* Maintenance of anesthesia was done with halothane. The incision was allowed at 1.2 MAC of halothane. This halogen was administered according to the hemodynamic parameters and the habits of the anesthesia team. Before waking up, all the patients benefited from preventive analgesia with 1 g paracetamol combined with 20 mg nefopam by slow intravenous injection over approximately 15 minutes.<br>|
| No Intervention: group 2<br>In classic induction: fentanyl at a dose of 2 µg/kg. Following induction in all patients consisted of the administration of propofol 2-3 mg/kg in titration, rocuronium 0.6 mg/kg, ketamine 0.5 mg/kg, methylprednisolone 120 mg. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest numerical pain score | The main highest numerical pain score postoperatively | First two hours postoperatively | 

Secondary Outcome Measures

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