Clinical trial NCT05031676: Opioid Free Anesthesia in Maxillofacial Surgery
Official title: Efficiency of Opioid-free Anesthesia (OFA) in Maxillofacial Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial Surgery
Lead sponsor: Université NAZI BONI
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 66
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Highest numerical pain score
timeFrame: First two hours postoperatively
Secondary outcomes:
measure: Blood pressure
timeFrame: six minutes after incision
measure: Ephedrine
timeFrame: During anesthesia
measure: Wake up
timeFrame: Time between the end of surgery and extubation
measure: Nausea-Vomiting
timeFrame: During 24 after surgery
measure: Highest numerical pain score 24 hours
timeFrame: The first 24 hours postoperatively
measure: Non-surgical complications
timeFrame: During 24 hours after surgery
measure: Heart rate
timeFrame: six minutes after incision
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Guibla
state: Houet
Study officials:
affiliation: University Hospital Souro Sanou, Burkina Faso
name: Ismael Guibla, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Souro Sanou, Burkina Faso
name: Charles Ilboudo, Doctor
role: STUDY_CHAIR
affiliation: Univesity of Joseph KI-ZERBO, Health sciences institute
name: Bertille Ki, Professor
role: STUDY_CHAIR
affiliation: Hospital of Charleroi (GHdC), Belgium
name: Jean Paul Lechat, Doctor
role: STUDY_CHAIR
affiliation: Univesity of Joseph KI-ZERBO, Health sciences institute
name: Cheick Bougouma, Doctor
role: STUDY_CHAIR
affiliation: University of Nazi Boni, Health sciences institute
name: Alain Traore, Professor
role: STUDY_DIRECTOR
affiliation: Univesity of Joseph KI-ZERBO, Health sciences institute
name: Flavien Kabore, Professor
role: STUDY_DIRECTOR
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