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Clinical Trials/NCT05031676
NCT05031676
Completed
Not Applicable

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

Université NAZI BONI1 site in 1 country66 target enrollmentFebruary 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillofacial Surgery
Sponsor
Université NAZI BONI
Enrollment
66
Locations
1
Primary Endpoint
Highest numerical pain score
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 15, 2019
End Date
October 5, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Université NAZI BONI
Responsible Party
Principal Investigator
Principal Investigator

Ismael Guibla

Anaesthesist

Université NAZI BONI

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

Outcomes

Primary Outcomes

Highest numerical pain score

Time Frame: First two hours postoperatively

The main highest numerical pain score postoperatively

Secondary Outcomes

  • Wake up(Time between the end of surgery and extubation)
  • Nausea-Vomiting(During 24 after surgery)
  • Highest numerical pain score 24 hours(The first 24 hours postoperatively)
  • Heart rate(six minutes after incision)
  • Blood pressure(six minutes after incision)
  • Ephedrine(During anesthesia)
  • Non-surgical complications(During 24 hours after surgery)

Study Sites (1)

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