Opioid Free Anesthesia in Maxillofacial Surgery

Université NAZI BONI

Status: Completed

Conditions: Maxillofacial Surgery

Treatments: Other: opioid free anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05031676

INSSA

Details and patient eligibility

About

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.

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

group 1

Experimental group

Description:

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.

Treatment:

Other: opioid free anesthesia

group 2

No Intervention group

Description:

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.