Intravenous Fluids After Laparoscopic Cholecystectomy

NCT03142464 — Not applicable, Completed, 100 participants, Federal University of Minas Gerais

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

Registry	NCT03142464
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Actual)
Sponsor	Federal University of Minas Gerais (Other)
Conditions	Postoperative Nausea, Postoperative Vomiting, Renal Function Abnormal, Hunger, Thirst, Fluid Electrolyte Disorders
Interventions	Suspension of the IV fluids (Other)
Dates	start 2015-07-01, primary completion 2016-07-30, completion 2016-07-30, first posted 2017-05-05, last updated 2017-05-08

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
IV fluids	No intervention		Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description
No IV fluids	Experimental	Other: Suspension of the IV fluids	No IV fluids after the termination of the operation. T

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

+Outcome measures

Primary outcomes

Renal function [24 hours]: Serum creatinine

Secondary outcomes

Presence of thirst [24 hours]: Visual analog scale
Presence of nausea [24 hours]: Visual analog scale
Total intravenous prescribed fluids per body weight [24 hours]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

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

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