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NCT05693402 Clinical Trial

Opioid-Free Anesthesia in Modified Radical Mastectomy

Surgery Clinical Trial

Official title:
Efficacy of Opioid-Free Anesthesia in Modified Radical Mastectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05693402
Other study ID # HelouAssaf
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2020

Study information
Verified date January 2023
Source Dr Etienne El Helou
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of opioid-free general anesthesia for breast surgeries in female patients.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date December 1, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients underwenting modified radical mastectomy - Undergoing general anesthesia Exclusion Criteria: - Patients were excluded if they had Alzheimer's Disease, mental retardation, failure of locoregional anesthesia, contraindication for locoregional anesthesia.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• opioid anesthesia
opioid-free general anesthesia vs non opioid-free general anesthesia

Locations
Country Name City State
Lebanon Lebanese Hospital Geitaoui-University Medical Center Beirut

Sponsors (1)
Lead Sponsor Collaborator
Etienne El Helou

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post operative Morphone use Patients who received Morphine at different time points in function of the two study groups up to 24 hours
Primary Time To Extubation (TTE) Time to Extubation in function of the two study groups Directly intraOp
Secondary Post Operative Nausea and Vomiting (PONV) Patients who had PONV at different times in function of the two study groups Up to 24hours
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