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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00226564
Other study ID # yc19554-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated October 28, 2008
Start date August 1997

Study information

Verified date October 2008
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

The response to opioids varies greatly among individuals. Some of these variability is accounted for by genetic factors.

The present study was designed to evaluate the possibility that genetic polymorphism in the gene encoding for mu opioid receptor may explain variability in the response to alfentanil during lithotripsy.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Age > 20

Exclusion Criteria:

- Regular use of opioid drugs

- Known hypersensitivity to alfentanil

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Alfentanil


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total alfentanil dose used during the procedure.
Primary The extent of respiratory depression.
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