Opioid Free Anesthesia in Maxillofacial Surgery

NCT05031676 | Completed

• 1 other identifier: INSSA
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillofacial Surgery

Outcome Measures

Primary Outcomes (1)

• Highest numerical pain score

  The main highest numerical pain score postoperatively

  First two hours postoperatively

Secondary Outcomes (7)

• Blood pressure

  six minutes after incision

• Ephedrine

  During anesthesia

• 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

Study Arms (2)

group 1

EXPERIMENTAL

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

group 2

NO INTERVENTION

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.

Interventions

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.

group 1

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged between 15 and 65 years, admitted to the central operating room of the hospital for maxillofacial surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université NAZI BONI: lead

Study Sites (1)

Guibla

Bobo-Dioulasso, Houet, Burkina Faso

Location

Related Publications (8)

• De Kock M. L'anesthésie sans opiacés : anecdote ou nécessité ? Douleur et Analgésie. 2014 sept;27(3):145-148.

  RESULT

• Beloeil H. Anesthésie sans opiacés. Anesth Réanimation. 2018 may;4(3):215-218.

  RESULT

• Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. No abstract available. English, Spanish.

  PMID: 28431750 RESULT

• Parsa FD, Cheng J, Stephan B, Castel N, Kim L, Murariu D, Parsa AA. Bilateral Breast Reduction Without Opioid Analgesics: A Comparative Study. Aesthet Surg J. 2017 Sep 1;37(8):892-899. doi: 10.1093/asj/sjx038.

  PMID: 28333299 RESULT

• Mansour MA, Mahmoud AA, Geddawy M. Nonopioid versus opioid based general anesthesia technique for bariatric surgery: A randomized double-blind study. Saudi J Anaesth. 2013 Oct;7(4):387-91. doi: 10.4103/1658-354X.121045.

  PMID: 24348288 RESULT

• Soffin EM, Wetmore DS, Beckman JD, Sheha ED, Vaishnav AS, Albert TJ, Gang CH, Qureshi SA. Opioid-free anesthesia within an enhanced recovery after surgery pathway for minimally invasive lumbar spine surgery: a retrospective matched cohort study. Neurosurg Focus. 2019 Apr 1;46(4):E8. doi: 10.3171/2019.1.FOCUS18645.

  PMID: 30933925 RESULT

• Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. [Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study]. Rev Bras Anestesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjan.2014.05.006. Epub 2014 Nov 1. Portuguese.

  PMID: 25990496 RESULT

• Toleska M, Dimitrovski A. Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2019 Oct 1;40(2):81-87. doi: 10.2478/prilozi-2019-0018.

  PMID: 31605587 RESULT

Study Officials

• Ismael Guibla, Doctor

  University Hospital Souro Sanou, Burkina Faso

  PRINCIPAL INVESTIGATOR

• Charles Ilboudo, Doctor

  University Hospital Souro Sanou, Burkina Faso

  STUDY CHAIR

• Bertille Ki, Professor

  Univesity of Joseph KI-ZERBO, Health sciences institute

  STUDY CHAIR

• Jean Paul Lechat, Doctor

  Hospital of Charleroi (GHdC), Belgium

  STUDY CHAIR

• Cheick Bougouma, Doctor

  Univesity of Joseph KI-ZERBO, Health sciences institute

  STUDY CHAIR

• Alain Traore, Professor

  University of Nazi Boni, Health sciences institute

  STUDY DIRECTOR

• Flavien Kabore, Professor

  Univesity of Joseph KI-ZERBO, Health sciences institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant does not know the protocol which receive but i
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesist

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: September 2, 2021
• Study Start: February 15, 2019
• Primary Completion: June 15, 2020
• Study Completion: October 5, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)