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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Highest numerical pain score | The main highest numerical pain score postoperatively | First two hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Changes in blood pressure | six minutes after incision |
| Ephedrine | Intraoperative consumption of ephedrine | During anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guibla | Bobo-Dioulasso | Houet | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 28431750 | 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. | |
| 28333299 |
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Use number and date to find participant folder. Participant data are confidential.
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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.
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Participant does not know the protocol which receive but i
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| Wake up | wake up time | Time between the end of surgery and extubation |
| Nausea-Vomiting | The proportion of nausea-vomiting after surgery | During 24 after surgery |
| Highest numerical pain score 24 hours | The mean of the highest EN score during the first 24 hours postoperatively | The first 24 hours postoperatively |
| Non-surgical complications | The proportion of non-surgical complications within 24 hours of anesthesia | During 24 hours after surgery |
| Heart rate | Changes in heart rate | six minutes after incision |
| 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. |
| 24348288 | 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. |
| 30933925 | 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. |
| 25990496 | 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. |
| 31605587 | 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. |