Kidney Function After Pneumoperitoneum and Analgesia

Overview

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

Full Title of Study: “Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2007

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.

Arms, Groups and Cohorts

  • group tramadol plus ketorolac
  • group tramadol plus dypirone

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UPECLIN HC FM Botucatu Unesp
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Clinical Research Ethic Comittee of Botucatu Medical School, Botucatu Medical School
  • Overall Official(s)
    • Yara M Castiglia, MD, PhD, Principal Investigator, Botucatu Medical School

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