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OpenTrials
Completed

NCT Number: NCT05031676

Opioid Free Anesthesia in Maxillofacial Surgery

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.

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Key information

Conditions

Maxillofacial Surgery

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guibla

Bobo-Dioulasso, Houet, Burkina Faso

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioid free anesthesia

Other

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.

Primary outcomes

  1. Highest numerical pain score

    Time frame: First two hours postoperatively

    The main highest numerical pain score postoperatively

Secondary outcomes

  1. Blood pressure

    Time frame: six minutes after incision

    Changes in blood pressure

  2. Ephedrine

    Time frame: During anesthesia

    Intraoperative consumption of ephedrine

  3. Wake up

    Time frame: Time between the end of surgery and extubation

    wake up time

  4. Nausea-Vomiting

    Time frame: During 24 after surgery

    The proportion of nausea-vomiting after surgery

  5. Highest numerical pain score 24 hours

    Time frame: The first 24 hours postoperatively

    The mean of the highest EN score during the first 24 hours postoperatively

  6. Non-surgical complications

    Time frame: During 24 hours after surgery

    The proportion of non-surgical complications within 24 hours of anesthesia

  7. Heart rate

    Time frame: six minutes after incision

    Changes in heart rate

Sponsors and collaborators

Lead sponsor

Université NAZI BONI

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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