An interventional study of opioid free anesthesia in Maxillofacial Surgery, sponsored by Université NAZI BONI. Completed at 1 site in Burkina Faso. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Université NAZI BONI · Not applicable, Interventional, and Other
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.
The patients were recruited at the University Hospital of Souro Sanou in Bobo Dioulasso
Université NAZI BONI is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Highest numerical pain score
The main highest numerical pain score postoperatively
Time frame: First two hours postoperatively
Blood pressure
Changes in blood pressure
Time frame: six minutes after incision
Ephedrine
Intraoperative consumption of ephedrine
Time frame: During anesthesia
Wake up
wake up time
Time frame: Time between the end of surgery and extubation
Nausea-Vomiting
The proportion of nausea-vomiting after surgery
Time frame: During 24 after surgery
Highest numerical pain score 24 hours
The mean of the highest EN score during the first 24 hours postoperatively
Time frame: The first 24 hours postoperatively
Non-surgical complications
The proportion of non-surgical complications within 24 hours of anesthesia
Time frame: During 24 hours after surgery
Heart rate
Changes in heart rate
Time frame: six minutes after incision
Plan to share: No — Use number and date to find participant folder. Participant data are confidential.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Université NAZI BONI