Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2019-02-15
2020-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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group 1
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.
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.
group 2
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unstable arterial hypertension
* Insulin-dependent diabetes
* Second degree atrioventricular block
* Neuro-vegetative dysautonomia;
* known allergy or intolerance to a drug of the protocols
15 Years
65 Years
ALL
No
Sponsors
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Université NAZI BONI
OTHER
Responsible Party
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Ismael Guibla
Anaesthesist
Principal Investigators
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Ismael Guibla, Doctor
Role: PRINCIPAL_INVESTIGATOR
University Hospital Souro Sanou, Burkina Faso
Charles Ilboudo, Doctor
Role: STUDY_CHAIR
University Hospital Souro Sanou, Burkina Faso
Bertille Ki, Professor
Role: STUDY_CHAIR
Univesity of Joseph KI-ZERBO, Health sciences institute
Jean Paul Lechat, Doctor
Role: STUDY_CHAIR
Hospital of Charleroi (GHdC), Belgium
Cheick Bougouma, Doctor
Role: STUDY_CHAIR
Univesity of Joseph KI-ZERBO, Health sciences institute
Alain Traore, Professor
Role: STUDY_DIRECTOR
University of Nazi Boni, Health sciences institute
Flavien Kabore, Professor
Role: STUDY_DIRECTOR
Univesity of Joseph KI-ZERBO, Health sciences institute
Locations
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Guibla
Bobo-Dioulasso, Houet, Burkina Faso
Countries
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References
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De Kock M. L'anesthésie sans opiacés : anecdote ou nécessité ? Douleur et Analgésie. 2014 sept;27(3):145-148.
Beloeil H. Anesthésie sans opiacés. Anesth Réanimation. 2018 may;4(3):215-218.
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.
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.
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.
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.
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.
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.
Other Identifiers
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INSSA
Identifier Type: -
Identifier Source: org_study_id
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