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Kidney Function After Pneumoperitoneum and Analgesia

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ClinicalTrials.gov Identifier: NCT00914875
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : June 5, 2009
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
UPECLIN HC FM Botucatu Unesp

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

Condition or disease
Laparoscopic Cholecystectomy

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac
Study Start Date : February 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Group/Cohort
group tramadol plus ketorolac
group tramadol plus dypirone




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol plus ketorolac or dypirone
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914875


Locations
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Brazil
UPECLIN
Botucatu, São Paulo, Brazil, 18600 000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Yara M Castiglia, MD, PhD Botucatu Medical School
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Responsible Party: Clinical Research Ethic Comittee of Botucatu Medical School, Botucatu Medical School
ClinicalTrials.gov Identifier: NCT00914875    
Other Study ID Numbers: upeclin/HC/FMB-Unesp-25
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009
Keywords provided by UPECLIN HC FM Botucatu Unesp:
kidney function tests
anti-inflammatory agents, non-steroidal
laparoscopic cholecystectomy
adult