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Genetic Determinants of Opioids Analgesia

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Alfentanil
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 20 Exclusion Criteria: Regular use of opioid drugs Known hypersensitivity to alfentanil

Sites / Locations

  • Hadassah Medical Organization

Outcomes

Primary Outcome Measures

Total alfentanil dose used during the procedure.
The extent of respiratory depression.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
October 28, 2008
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00226564
Brief Title
Genetic Determinants of Opioids Analgesia
Official Title
The Effect of mu Opioid Receptor Polymorphism on the Response to Alfentanil During Lithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alfentanil
Primary Outcome Measure Information:
Title
Total alfentanil dose used during the procedure.
Title
The extent of respiratory depression.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 20 Exclusion Criteria: Regular use of opioid drugs Known hypersensitivity to alfentanil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoseph Caraco, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Genetic Determinants of Opioids Analgesia

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