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Kidney Function After Pneumoperitoneum and Analgesia

This study has been completed.
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 Identifier:
First received: June 3, 2009
Last updated: June 4, 2009
Last verified: June 2009
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

Laparoscopic Cholecystectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac

Resource links provided by NLM:

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment: 126
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
group tramadol plus ketorolac
group tramadol plus dypirone

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.


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00914875

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.
Principal Investigator: Yara M Castiglia, MD, PhD Botucatu Medical School
  More Information

Responsible Party: Clinical Research Ethic Comittee of Botucatu Medical School, Botucatu Medical School Identifier: NCT00914875     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-25
Study First Received: June 3, 2009
Last Updated: June 4, 2009

Keywords provided by UPECLIN HC FM Botucatu Unesp:
kidney function tests
anti-inflammatory agents, non-steroidal
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants processed this record on May 25, 2017