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NCT03142464 Clinical Trial

Intravenous Fluids After Laparoscopic Cholecystectomy

Postoperative Nausea Clinical Trial

Official title:
Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03142464
Other study ID # 102908/2015
Secondary ID
Status Completed
Phase N/A
First received April 9, 2017
Last updated May 5, 2017
Start date July 1, 2015
Est. completion date July 30, 2016

Study information
Verified date May 2017
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 30, 2016
Est. primary completion date July 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Suspension of the IV fluids
No IV fluids prescription, IV catheter filled with saline solution

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Federal University of Minas Gerais

Outcome
Type Measure Description Time frame Safety issue
Primary Renal function Serum creatinine 24 hours
Secondary Presence of thirst Visual analog scale 24 hours
Secondary Presence of nausea Visual analog scale 24 hours
Secondary Total intravenous prescribed fluids per body weight 24 hours
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