Drug AddictionNCT05803044
Importance of Drug User Detection
An observational study of Drug Addiction, run by Assiut University.
Trial summary
1. Identify the illicit drugs (morphine, cannabinoids, benzodiazepines, barbiturates, tramadol, cocaine, amphetamine, alcohol, synthetic cannabinoids). 2. Identify illicit drug users in patients who admitted in Assiut University Hospitals undergoing emergency operation and their percent among all patients admitted for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drug Addiction
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Dec 2024
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Two hundred patients who undergoing emergency operation of both sexes, in age group more than 18 years will be included in the study.
Who may be able to join
- Emergency operations.
- Age group more than 18 years.
Who cannot join
- -Age group less than 18 years.
- Patients refuse to be included in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Medico Legal Importance of Drug Abuse Detection Before Emergency Operation
- Identify the illicit drugs (morphine, cannabinoids, benzodiazepines, barbiturates, tramadol, cocaine, amphetamine, alcohol, synthetic cannabinoids).
- Identify illicit drug users in patients who admitted in Assiut University Hospitals undergoing emergency operation and their percent among all patients admitted for emergency operation, for proper selection of anaesthetic agents and proper care before, during and after operations.
- Compare between addict and non addict in using suitable anaesthetic agents and doses - period of anaesthesia- period of recovery- complications.
- Compare between addict and non addict patients in :( vital signs before, during and after operation by using anaesthetic chart).
- Identify the importance of using drug abuse detection as a routine lab work before urgent operations.
Read the detailed description
Drug addiction has become a more common problem worldwide. In many countries drug abuse is rapidly increasing among young generations .By taking routine preoperative history, it has been noticed that there is a high percentage of patients who were addicted to different types of drugs. Drug addiction remarkably increases morbidity and mortality among patients. Addiction could be defined as a chronic disorder characterized by the compulsive use of a substance, resulting in physical, psychological or social harm to the user and continued use despite that harm .
Substances that could be abused are so many: alcohol, sedative and hypnotics, opioids, cocaine and amphetamines, cannabis, hallucinogens and nicotine. They can be classified as socially acceptable drug (e.g., alcohol, tobacco), a medically prescribed drug (e.g., diazepam), and illegal substance (e.g., cocaine) .
Both acute intoxication and chronic abuse of these substances present challenges for anesthetic management during and after an operation .Whereas some procedures may be delayed while the issue is addressed, others are urgent or emergent and the surgeon and anesthesiologist must be able to deal with the physiologic changes that may occur in these patients.
So, it is important to understand the situations of drug users, such as the category of drugs used, the dosage, the duration of drug use, their history of detoxification or abstention, and especially their current abuse of drugs. Pain threshold in addicts is lower than ordinary people who are not addict to opium due to several reasons including change in function, sensitivity reduction, or decrease in opioid's receptors.
Nevertheless, they are more resistant against narcotics and analgesic drugs. With little information about the history of drug abuse, a quick screening for recent use of drugs is important for both medical staff and patients. The immune colloidal gold (ICG) technique is a well-established technique and is commonly used for screening for drug abuse .
Awareness of the drug's pharmacodynamics, pharmacokinetics and interaction with anesthetics medication is crucial to the proper management of illicit drug users during the perioperative period. Moreover, it is common for illicit drug users to have infection with human immune-deficiency virus (HIV), hepatic C virus (HCV), syphilis or other sexually transmitted disease (STD), which may put medical staff in danger. Incidences of intraoperative and postoperative complications are increased in illicit drug users such as pulmonary infection and coagulation disorders .
Death of drug abusers during anaesthesia and intra operative may occur due to severe cardiovascular cocaine toxicity if general stabilization and hemodynamic control not achieved .
The preventable perioperative complications are evaluated to improve the safety of health care, including also the medical-law point of view .
On the other side, research was done in 2016 at Johans Hopkins found that the average of 250.000 people die in US because of medical errors each year. Updating for this study in 2020 found that the serious medical errors occur most frequently in ICU, emergency departments and operation rooms. Many lawsuits are filled each year against doctors.
For these reasons and more it is important, to the patients and medical staff, to make preoperative drug abuse analysis as a mandatory before emergency surgeries to achieve optimal management during and after operations.
- Conditions
- Drug Addiction
- Medical subject headings
- Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
By using an anaesthetic record sheat
which will include
- physiological parameter as:
- age (years)
- weight (kg)
- blood pressure(mmHg)
- heart rate(beat /min)
- respiratory rate(breath/ min)
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Sadek Tolba, Assiut University
- Investigators
- Doaa Mohamed Almaz, lecturer, Study director, SupervisionShimaa Abass Hassan, Lecturer, Study director, Supervision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803044
- Sponsor's protocol ID
- Drug users detection
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Ma H, Liao R, Huang Y, Chen G. Preoperative screening for illicit drug use in patients undergoing emergency surgery: A prospective observational study. Sci Rep. 2018 May 9;8(1):7405. doi: 10.1038/s41598-018-25829-3.
PubMed 29743682Mansourian A, Askarzadeh M, Shabani M, Divsalar K. Comparison of Duration of Spinal Anesthesia with Lidocaine or Lidocaine plus Epinephrine between Addicts and Non-addicts. Addict Health. 2012 Summer-Autumn;4(3-4):95-101.
PubMed 24494142
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico Legal Importance of Drug Abuse Detection Before Emergency Operation
- ClinicalTrials.gov ID
- NCT05803044
- Acronym / sponsor ID
- Drug users detection
- Conditions
- Drug Addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Apr 2023 (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.
- Identify the illicit drugs (morphine, cannabinoids, benzodiazepines, barbiturates, tramadol, cocaine, amphetamine, alcohol, synthetic cannabinoids).
- Identify illicit drug users in patients who admitted in Assiut University Hospitals undergoing emergency operation and their percent among all patients admitted for emergency operation, for proper selection of anaesthetic agents and proper care before, during and after operations.
- Compare between addict and non addict in using suitable anaesthetic agents and doses - period of anaesthesia- period of recovery- complications.
- Compare between addict and non addict patients in :( vital signs before, during and after operation by using anaesthetic chart).
- Identify the importance of using drug abuse detection as a routine lab work before urgent operations.
Detailed description
Drug addiction has become a more common problem worldwide. In many countries drug abuse is rapidly increasing among young generations .By taking routine preoperative history, it has been noticed that there is a high percentage of patients who were addicted to different types of drugs. Drug addiction remarkably increases morbidity and mortality among patients. Addiction could be defined as a chronic disorder characterized by the compulsive use of a substance, resulting in physical, psychological or social harm to the user and continued use despite that harm .
Substances that could be abused are so many: alcohol, sedative and hypnotics, opioids, cocaine and amphetamines, cannabis, hallucinogens and nicotine. They can be classified as socially acceptable drug (e.g., alcohol, tobacco), a medically prescribed drug (e.g., diazepam), and illegal substance (e.g., cocaine) .
Both acute intoxication and chronic abuse of these substances present challenges for anesthetic management during and after an operation .Whereas some procedures may be delayed while the issue is addressed, others are urgent or emergent and the surgeon and anesthesiologist must be able to deal with the physiologic changes that may occur in these patients.
So, it is important to understand the situations of drug users, such as the category of drugs used, the dosage, the duration of drug use, their history of detoxification or abstention, and especially their current abuse of drugs. Pain threshold in addicts is lower than ordinary people who are not addict to opium due to several reasons including change in function, sensitivity reduction, or decrease in opioid's receptors.
Nevertheless, they are more resistant against narcotics and analgesic drugs. With little information about the history of drug abuse, a quick screening for recent use of drugs is important for both medical staff and patients. The immune colloidal gold (ICG) technique is a well-established technique and is commonly used for screening for drug abuse .
Awareness of the drug's pharmacodynamics, pharmacokinetics and interaction with anesthetics medication is crucial to the proper management of illicit drug users during the perioperative period. Moreover, it is common for illicit drug users to have infection with human immune-deficiency virus (HIV), hepatic C virus (HCV), syphilis or other sexually transmitted disease (STD), which may put medical staff in danger. Incidences of intraoperative and postoperative complications are increased in illicit drug users such as pulmonary infection and coagulation disorders .
Death of drug abusers during anaesthesia and intra operative may occur due to severe cardiovascular cocaine toxicity if general stabilization and hemodynamic control not achieved .
The preventable perioperative complications are evaluated to improve the safety of health care, including also the medical-law point of view .
On the other side, research was done in 2016 at Johans Hopkins found that the average of 250.000 people die in US because of medical errors each year. Updating for this study in 2020 found that the serious medical errors occur most frequently in ICU, emergency departments and operation rooms. Many lawsuits are filled each year against doctors.
For these reasons and more it is important, to the patients and medical staff, to make preoperative drug abuse analysis as a mandatory before emergency surgeries to achieve optimal management during and after operations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Two hundred patients who undergoing emergency operation of both sexes, in age group more than 18 years will be included in the study.
Key inclusion criteria (2 listed)
- Emergency operations.
- Age group more than 18 years.
Key exclusion criteria (2 listed)
- -Age group less than 18 years.
- Patients refuse to be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
By using an anaesthetic record sheat
Time frame: basline
which will include * physiological parameter as: * age (years) * weight (kg) * blood pressure(mmHg) * heart rate(beat /min) * respiratory rate(breath/ min)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 29743682Li J, Ma H, Liao R, Huang Y, Chen G. Preoperative screening for illicit drug use in patients undergoing emergency surgery: A prospective observational study. Sci Rep. 2018 May 9;8(1):7405. doi: 10.1038/s41598-018-25829-3.
- Background: PubMed 24494142Mansourian A, Askarzadeh M, Shabani M, Divsalar K. Comparison of Duration of Spinal Anesthesia with Lidocaine or Lidocaine plus Epinephrine between Addicts and Non-addicts. Addict Health. 2012 Summer-Autumn;4(3-4):95-101.
- Raynes M and Lawn M(2022):shocking medical malpractice statistics for 2021Link provided by the sponsor.
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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.
Doaa Mohamed Almaz, lecturer study director
Supervision
Shimaa Abass Hassan, Lecturer study director
Supervision
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Addiction, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa Sadek Tolba (01101276466, wafaasadek625@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
By using an anaesthetic record sheat (time frame: basline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803044, which also lists 2 linked publications.
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 7 Apr 2023.