Observational Study of Preoperative Screen for Substance Abuse

April 1, 2017 updated by: Ren Liao, West China Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1031

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

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan 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

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The trauma patients undergoing emergency operation

Description

Inclusion Criteria:

  • Patients aged 16~70 years；
  • Informed consent signed

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Drug: Substance use
Patients are found use of substances by preoperative screen
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative consumption of medications
Time Frame: 1 day
Perioperative consumption of sulfentanil, midazolam, propofol, and muscle relaxant in substance abusers and non-abusers.
1 day
Incidence and severity of postoperative complications
Time Frame: 30 days
30 days

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of HIV, HCV, syphilis positive in substance abusers and non-abusers.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Study Director: Ren Liao, M.D., West China Hospital

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

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 1, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCH2015-100

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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