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Intravenous Fluids After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Nausea, Postoperative Vomiting, Renal Function Abnormal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suspension of the IV fluids
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea focused on measuring saline solution, laparoscopy, cholecystectomy, outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

Exclusion Criteria: Co-existing severe renal failure, cardiac failure or pulmonary disease

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    IV fluids

    No IV fluids

    Arm Description

    Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description

    No IV fluids after the termination of the operation. T

    Outcomes

    Primary Outcome Measures

    Renal function
    Serum creatinine

    Secondary Outcome Measures

    Presence of thirst
    Visual analog scale
    Presence of nausea
    Visual analog scale
    Total intravenous prescribed fluids per body weight

    Full Information

    First Posted
    April 9, 2017
    Last Updated
    May 5, 2017
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03142464
    Brief Title
    Intravenous Fluids After Laparoscopic Cholecystectomy
    Official Title
    Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    July 30, 2016 (Actual)
    Study Completion Date
    July 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.
    Detailed Description
    Patients undergoing elective laparoscopy cholecystectomies were randomized to either routine practice fluid prescription (control group) or no IV fluids in the postoperative period. Thirst, hunger, presence of nausea and vomiting, renal function and personal satisfaction were assessed. Body composition was evaluated by bioimpedance

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea, Postoperative Vomiting, Renal Function Abnormal, Hunger, Thirst, Fluid Electrolyte Disorders
    Keywords
    saline solution, laparoscopy, cholecystectomy, outcomes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Controls - convention postoperative IV fluids; intervention arm - no IV fluids postoperative
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IV fluids
    Arm Type
    No Intervention
    Arm Description
    Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description
    Arm Title
    No IV fluids
    Arm Type
    Experimental
    Arm Description
    No IV fluids after the termination of the operation. T
    Intervention Type
    Other
    Intervention Name(s)
    Suspension of the IV fluids
    Intervention Description
    No IV fluids prescription, IV catheter filled with saline solution
    Primary Outcome Measure Information:
    Title
    Renal function
    Description
    Serum creatinine
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Presence of thirst
    Description
    Visual analog scale
    Time Frame
    24 hours
    Title
    Presence of nausea
    Description
    Visual analog scale
    Time Frame
    24 hours
    Title
    Total intravenous prescribed fluids per body weight
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication - Exclusion Criteria: Co-existing severe renal failure, cardiac failure or pulmonary disease -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intravenous Fluids After Laparoscopic Cholecystectomy

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