NCT00914875

Brief Summary

double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Shorter than P25 for all trials

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

February 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

June 3, 2009

Last Update Submit

June 4, 2009

Conditions

Laparoscopic Cholecystectomy

Keywords

kidney function testsanti-inflammatory agents, non-steroidallaparoscopic cholecystectomyadult

Study Arms (2)

group tramadol plus ketorolac

group tramadol plus dypirone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol plus ketorolac or dypirone

You may qualify if:

  • From 18 to 60 years
  • Normal kidney function
  • Free consented participation

You may not qualify if:

  • Renal and hepatic dysfunction
  • Prior (one month) use of anti-inflammatory agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPECLIN

Botucatu, São Paulo, 18600 000, Brazil

Location

Study Officials

  • Yara M Castiglia, MD, PhD

    Botucatu Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 5, 2009

Study Start

February 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

BR(1)