NCT00226564

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

First QC Date

September 12, 2005

Last Update Submit

October 28, 2008

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (2)

  • Total alfentanil dose used during the procedure.

  • The extent of respiratory depression.

Interventions

AlfentanilDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 20

You may not qualify if:

  • Regular use of opioid drugs
  • Known hypersensitivity to alfentanil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Alfentanil

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yoseph Caraco, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 27, 2005

Study Start

August 1, 1997

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

IL(1)