Kidney Function After Pneumoperitoneum and Analgesia

NCT ID: NCT00914875

Last Updated: 2009-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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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

Detailed Description

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Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. This prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and enzymuria evaluations.

Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) - were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1, n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of rescue analgesia with morphine were evaluated.

Conditions

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Laparoscopic Cholecystectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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group tramadol plus ketorolac

No interventions assigned to this group

group tramadol plus dypirone

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Renal and hepatic dysfunction
* Prior (one month) use of anti-inflammatory agents
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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Botucatu Medical School

Principal Investigators

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Yara M Castiglia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Botucatu Medical School

Locations

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UPECLIN

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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upeclin/HC/FMB-Unesp-25

Identifier Type: -

Identifier Source: org_study_id

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