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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source Université NAZI BONI
Contact n/a
Is FDA regulated No
Health authority
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


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Study Design


Related Conditions & MeSH terms


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)

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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
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