Maxillofacial Surgery Clinical Trial
Official title:
Efficiency of Opioid-free Anesthesia (OFA) in Maxillofacial Surgery
NCT number | NCT05031676 |
Other study ID # | INSSA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 15, 2019 |
Est. completion date | October 5, 2020 |
Verified date | August 2021 |
Source | Université NAZI BONI |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Guibla | Bobo-Dioulasso | Houet |
Lead Sponsor | Collaborator |
---|---|
Université NAZI BONI |
Burkina Faso,
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
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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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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