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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02621411
Other study ID # WCH2015-100
Secondary ID
Status Completed
Phase N/A
First received December 1, 2015
Last updated April 1, 2017
Start date November 2015
Est. completion date March 2017

Study information

Verified date April 2017
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 1031
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Substance use
Patients are found use of substances by preoperative screen

Locations

Country Name City State
China West China Hospital, Sichuan University Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of HIV, HCV, syphilis positive in substance abusers and non-abusers. 1 day
Primary 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 1 year
Secondary Perioperative consumption of medications Perioperative consumption of sulfentanil, midazolam, propofol, and muscle relaxant in substance abusers and non-abusers. 1 day
Secondary Incidence and severity of postoperative complications 30 days