Drug AbuseNCT05123521
Drug Abuse Among Elective Surgeries: an Observational Study.
An observational study of Drug Abuse, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Drug Abuse
- What is being tested?
- urine analysis
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 28 Feb 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- Child, Adult
Study population: those who had presented to the General Surgery or Orthopaedics Departments
Who may be able to join
- 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.
Who cannot join
- emergency surgery
- those with disturbed conscious levels
- history of psychological illness
- who refused to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Abuse
- Being tested
- urine analysis
- Keywords
- drug abuse, Cairo Teaching Hospital, elective surgery
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine analysisDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
urine analysis
multi-drug screen panel dip steak (Abon Biopharm (Hangzhou) , Ltd)
Measured: THREE MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Aug 2018
- Primary completion28 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
- Investigators
- Hassan Ali, Md, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123521
- Sponsor's protocol ID
- amera master
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Drug Abuse at the Cairo University Teaching Hospital Among Patients Who Underwent Elective Surgeries
- ClinicalTrials.gov ID
- NCT05123521
- Acronym / sponsor ID
- amera master
- Conditions
- Drug Abuse
- Keywords
- drug abuse, Cairo Teaching Hospital, elective surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- those who had presented to the General Surgery or Orthopaedics Departments
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- emergency surgery
- those with disturbed conscious levels
- history of psychological illness
- who refused to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine analysisUrine 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. | Diagnostic test | – |
Primary outcome
urine analysis
Time frame: THREE MONTHS
multi-drug screen panel dip steak (Abon Biopharm (Hangzhou) , Ltd)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Ali, Md principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Abuse, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine analysis (time frame: THREE MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.