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Renal Function During Laparoscopic Surgery

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Completed
CT.gov ID
NCT01722630
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
7
Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control

Patients received intravenously saline solution at 5 ml/Kg/h
Experimental: dopamine

Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min

Drug: Dopamine
Other Names:
  • Revivan

    		•
    No Intervention: crystalloids

    Patients received intravenously saline solution at 10 ml/Kg/h

    Outcome Measures

    Primary Outcome Measures

    1. estimated glomerular filtration rate, tissue Doppler imaging, E/Ea [patients will be followed for the duration of surgery, an expected average of 3 hours]

      EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.

    Secondary Outcome Measures

    1. total intra operative diuresis (TID) [patients will be followed for the duration of surgery, an expected average of 3 hours]

      TID will be measured at the end of surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA I

    • age 24-42

    • patients undergoing gynaecological laparoscopy

    Exclusion Criteria:

    • cardiovascular diseases

    • renal and endocrine disorders

    • obesity (BMI > 30 Kg/m2)

    • the assumption of drugs that could interfere with renal parameters considered in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catholic University of the sacred Heart Rome Italy 00168

    Sponsors and Collaborators

    • Catholic University of the Sacred Heart

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesca Bevilacqua, Medical Doctor, Catholic University of the Sacred Heart
    ClinicalTrials.gov Identifier:
    NCT01722630
    Other Study ID Numbers:
    • FRF-2012-DH
    First Posted:
    Nov 7, 2012
    Last Update Posted:
    Nov 7, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Francesca Bevilacqua, Medical Doctor, Catholic University of the Sacred Heart
    dopamine
    laparoscopy
    fluid management
    Additional relevant MeSH terms:
    Dopamine

    Study Results

    No Results Posted as of Nov 7, 2012