Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency OperationNCT02621411
Observational Study of Preoperative Screen for Substance Abuse
An observational study of Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency Operation, run by West China Hospital at 1 site in China.
Trial summary
Substance abuse is a growing problem world wide, and treatment of substance abusers in the perioperative period, especially for emergency operation is challenging. The objectives of this study are to determine the proportions of substance abusers in the trauma patients undergoing emergency operation by preoperative… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency Operation
- What is being tested?
- Substance use
- How many people
- 1,031 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Mar 2017
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The trauma patients undergoing emergency operation
Who may be able to join
- Patients aged 16~70 years；
- Informed consent signed
Who cannot join
- Aged<16 years or >70 years；
- Refuse to sign consent;
- Other conditions that may preclude the patients from the study, such as language barrier, psychiatric disorders, unable to attend research center for follow up.
- Patients who enrolled to another research study or are taking experimental medication in last 3 months prior to this study.
- Not suitable for the study, after assessment by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Screen for Substance Abuse in Trauma Patients Undergoing Emergency Operation: a Prospective Observational Study
Substance abuse is a growing problem world wide, and treatment of substance abusers in the perioperative period, especially for emergency operation is challenging. The objectives of this study are to determine the proportions of substance abusers in the trauma patients undergoing emergency operation by preoperative screen, observe the differences of consumption of anesthetics and other medications during perioperative period between substance abusers and non-abusers, as well as postoperative complications, and explore an optimal scheme for substance abusers.
- Being tested
- Substance use
- Keywords
- Substance abuse, Emergency operation, Preoperative screen
- 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.
Substance useDrug
Patients are found use of substances by preoperative screen
| Study group | Role | What they receive |
|---|---|---|
| Substance abuser group | After preoperative screen by application of ICG test cassette, this group of patients are found current use of the certain substance(s). Receives: Drug: Substance use | |
| Non-substance abuser group | After preoperative screen by application of ICG test cassette, this group of patients are not found use of any substance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of substance abuser in all the emergency operation patients
The proportion will be calculated as the number of substance abusers / total number of enrolled calculated as the number of substance abusers / total number of enrolled patients
Measured: 1 year
Secondary outcomes (2)
Perioperative consumption of medications
Perioperative consumption of sulfentanil, midazolam, propofol, and muscle relaxant in substance abusers and non-abusers.
Measured: 1 day
Incidence and severity of postoperative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency OperationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- 1,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621411
- Sponsor's protocol ID
- WCH2015-100
- Status last verified
- Apr 2017
- First submitted
- 1 Dec 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Screen for Substance Abuse in Trauma Patients Undergoing Emergency Operation: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02621411
- Acronym / sponsor ID
- WCH2015-100
- Keywords
- Substance abuse, Emergency operation, Preoperative screen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,031 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
Substance abuse is a growing problem world wide, and treatment of substance abusers in the perioperative period, especially for emergency operation is challenging. The objectives of this study are to determine the proportions of substance abusers in the trauma patients undergoing emergency operation by preoperative screen, observe the differences of consumption of anesthetics and other medications during perioperative period between substance abusers and non-abusers, as well as postoperative complications, and explore an optimal scheme for substance abusers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substance abuser group | – | Drug: Substance useAfter preoperative screen by application of ICG test cassette, this group of patients are found current use of the certain substance(s). |
| Non-substance abuser group | – | –After preoperative screen by application of ICG test cassette, this group of patients are not found use of any substance. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The trauma patients undergoing emergency operation
Key inclusion criteria (2 listed)
- Patients aged 16~70 years；
- Informed consent signed
Key exclusion criteria (5 listed)
- Aged<16 years or >70 years；
- Refuse to sign consent;
- Other conditions that may preclude the patients from the study, such as language barrier, psychiatric disorders, unable to attend research center for follow up.
- Patients who enrolled to another research study or are taking experimental medication in last 3 months prior to this study.
- Not suitable for the study, after assessment by the investigators.
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 |
|---|---|---|
| Substance usePatients are found use of substances by preoperative screen | Drug | Substance abuser group |
Primary outcome
Proportion of substance abuser in all the emergency operation patients
Time frame: 1 year
The proportion will be calculated as the number of substance abusers / total number of enrolled calculated as the number of substance abusers / total number of enrolled patients
2 secondary outcomes
Perioperative consumption of medications
Time frame: 1 day
Incidence and severity of postoperative complications
Time frame: 30 days
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 4 Apr 2017.
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.
Ren Liao, M.D. study director
West China Hospital
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 Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency Operation, run by West China Hospital at 1 site in China.
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 5 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 4 Apr 2017. 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 China. 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?
Proportion of substance abuser in all the emergency operation patients (time frame: 1 year). 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 4 Apr 2017.