Maxillofacial Surgery
Conditions
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
Interventions
OTHERopioid free anesthesia
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.
Sponsors
Université NAZI BONI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participant does not know the protocol which receive but i
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Highest numerical pain score | First two hours postoperatively | The main highest numerical pain score postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ephedrine | During anesthesia | Intraoperative consumption of ephedrine |
| 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 |
| Blood pressure | six minutes after incision | Changes in blood pressure |
| Non-surgical complications | During 24 hours after surgery | The proportion of non-surgical complications within 24 hours of anesthesia |
| Heart rate | six minutes after incision | Changes in heart rate |
| Highest numerical pain score 24 hours | The first 24 hours postoperatively | The mean of the highest EN score during the first 24 hours postoperatively |
Countries
Burkina Faso
Outcome results
None listed