- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123521
Drug Abuse Among Elective Surgeries: an Observational Study.
November 5, 2021 updated by: Hassan Mohamed Ali, Cairo University
Incidence of Drug Abuse at the Cairo University Teaching Hospital Among Patients Who Underwent Elective Surgeries
Drug abusers and addicts form a challenge to the anesthetist because of the added potential risks involved in the administration of anesthesia to this subset of patients, including potential unforeseen drug-drug interactions.
In this study, we aimed at screening all patients scheduled for elective orthopedic or general surgeries at the Cairo University Teaching Hospital during a set period of time for the most commonly abused drugs in Egypt.
Study Overview
Detailed Description
All patients included in the study consented to take part in this study.
Each patient was asked to answer a questionnaire and submit a urine sample in order to be screened for the most commonly abused drugs in Egypt (hashish, tramadol, benzodiazepine, and morphine).
Patients were then followed up both intra and post-operatively.
Values of patient vital signs, Richmond Agitation-Sedation Scale (RASS) scores as well as clinical recovery scores (CRS) were all diligently recorded and analyzed.
Study Type
Observational
Enrollment (Actual)
500
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
-
-
Giza
-
Cairo, Giza, Egypt, 1234
- Cairo University
-
-
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
15 years to 60 years (ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
those who had presented to the General Surgery or Orthopaedics Departments
Description
Inclusion Criteria:
- male or female patients classified as American Society of Anaesthesiology (ASA) I or II patients
- patients between 15 and 60 years of age
- patients scheduled for elective surgery.
Exclusion Criteria:
- emergency surgery
- those with disturbed conscious levels
- history of psychological illness
- who refused to give consent
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
urine analysis
Time Frame: THREE MONTHS
|
multi-drug screen panel dip steak (Abon Biopharm (Hangzhou) , Ltd)
|
THREE MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hassan Ali, Md, Cairo University
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)
August 1, 2018
Primary Completion (ACTUAL)
January 28, 2019
Study Completion (ACTUAL)
February 28, 2019
Study Registration Dates
First Submitted
October 23, 2021
First Submitted That Met QC Criteria
November 5, 2021
First Posted (ACTUAL)
November 17, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2021
Last Update Submitted That Met QC Criteria
November 5, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- amera master
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.
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