- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693402
Opioid-Free Anesthesia in Modified Radical Mastectomy
January 11, 2023 updated by: Etienne El Helou
Efficacy of Opioid-Free Anesthesia in Modified Radical Mastectomy
The aim of this study is to evaluate the efficacy of opioid-free general anesthesia for breast surgeries in female patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
116
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beirut, Lebanon
- Lebanese Hospital Geitaoui-University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Between January 2018 and September 2020, data from admitted patients for modified radical mastectomy under general anesthesia were enrolled.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1 consisting of treated patients using OFA
Group 1 consisted of 56 (Mean age was 54±14 years)
|
|
Group 2 consisting of treated patients using NOFA
Group 2 consisted of 60 patients (Mean age was 51±12 years)
|
opioid-free general anesthesia vs non opioid-free general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post operative Morphone use
Time Frame: up to 24 hours
|
Patients who received Morphine at different time points in function of the two study groups
|
up to 24 hours
|
Time To Extubation (TTE)
Time Frame: Directly intraOp
|
Time to Extubation in function of the two study groups
|
Directly intraOp
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post Operative Nausea and Vomiting (PONV)
Time Frame: Up to 24hours
|
Patients who had PONV at different times in function of the two study groups
|
Up to 24hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
December 16, 2022
First Submitted That Met QC Criteria
January 11, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 11, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HelouAssaf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
Clinical Trials on opioid anesthesia
-
AZ Sint-Jan AVCompletedDecreased Lung Compliance | Oxygen RequirementBelgium
-
NorthShore University HealthSystemRecruitingHiatal HerniaUnited States
-
Beijing Chao Yang HospitalRecruitingThoracic Diseases | Postoperative Nausea and Vomiting | Opioid UseChina
-
University of CreteRecruitingSystemic Inflammatory Response Syndrome | Non-small Cell Lung Cancer | Anesthesia | Opioid Use | Postoperative Pain, Acute | Postoperative Pain, Chronic | Infections PostoperativeGreece
-
University of CreteUniversity Hospital of CreteRecruitingPostoperative Pain | Anesthesia | Opioid Use | Interleukin 6 | Elective Surgical Procedures | Abdominal Aortic Aneurysm Without Rupture | Vascular Surgical Procedure | ImmunomodulatorsGreece
-
Lebanese American UniversityCompletedPostoperative Pain | Opioid Use | Spine DiseaseLebanon
-
Peking University People's HospitalCompleted
-
Zulekha HospitalsCompleted
-
Northwell HealthRecruiting