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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05123521
Other study ID # amera master
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date February 28, 2019

Study information

Verified date November 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date February 28, 2019
Est. primary completion date January 28, 2019
Accepts healthy volunteers
Gender All
Age group 15 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
urine analysis
Urine was then tested for evidence of substance abuse using the multi-drug screen panel dip steak ABONtm (Abon Biopharm (Hangzhou) CO., Ltd) which is a lateral flow chromatographic immunoassay . It allowed for qualitative detection of multiple drugs in a single run. This kit was chosen for its ability to detect the most commonly abused substances in Egypt, namely: opioids, benzodiazepines, hashish, and tramadol. A single coloured line at region C for of a specific drug indicated a positive result, whilst two coloured lines at both regions C and T indicated a negative result. The absence of coloured lines was an indication of the invalidity of the particular kit, and the kit was discarded.

Locations

Country Name City State
Egypt Cairo University Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary urine analysis multi-drug screen panel dip steak (Abon Biopharm (Hangzhou) , Ltd) THREE MONTHS
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