Opioid Free Anesthesia in Maxillofacial Surgery

Maxillofacial Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031676
• Other study ID #: INSSA
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: October 5, 2020

Study information

• Verified date: August 2021
• Source: Université NAZI BONI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 5, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Maxillofacial Surgery

Intervention

Other:
• opioid 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.

Locations

Country	Name	City	State
Burkina Faso	Guibla	Bobo-Dioulasso	Houet

Sponsors (1)

Lead Sponsor	Collaborator
Université NAZI BONI

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (8)

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]. — View Citation

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

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

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. — View Citation

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. English, Spanish. — View Citation

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. — View Citation

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 — View Citation

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-20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest numerical pain score	The main highest numerical pain score postoperatively	First two hours postoperatively
Secondary	Blood pressure	Changes in blood pressure	six minutes after incision
Secondary	Ephedrine	Intraoperative consumption of ephedrine	During anesthesia
Secondary	Wake up	wake up time	Time between the end of surgery and extubation
Secondary	Nausea-Vomiting	The proportion of nausea-vomiting after surgery	During 24 after surgery
Secondary	Highest numerical pain score 24 hours	The mean of the highest EN score during the first 24 hours postoperatively	The first 24 hours postoperatively
Secondary	Non-surgical complications	The proportion of non-surgical complications within 24 hours of anesthesia	During 24 hours after surgery
Secondary	Heart rate	Changes in heart rate	six minutes after incision