Intravenous Fluids After Laparoscopic Cholecystectomy

• Sponsor: Federal University of Minas Gerais (Other)
• Overall Status: Completed
• CT.gov ID: NCT03142464
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Actual Duration (Months): 13

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea; Postoperative Vomiting; Renal Function Abnormal; Hunger; Thirst; Fluid Electrolyte Disorders	Other: Suspension of the IV fluids	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Controls - convention postoperative IV fluids; intervention arm - no IV fluids postoperativeControls - convention postoperative IV fluids; intervention arm - no IV fluids postoperative
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jul 30, 2016
• Actual Study Completion Date: Jul 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: IV fluids Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description
Experimental: No IV fluids No IV fluids after the termination of the operation. T	Other: Suspension of the IV fluids; No IV fluids prescription, IV catheter filled with saline solution

Outcome Measures

Primary Outcome Measures

1. Renal function [24 hours]

   Serum creatinine

Secondary Outcome Measures

1. Presence of thirst [24 hours]

   Visual analog scale

2. Presence of nausea [24 hours]

   Visual analog scale

3. Total intravenous prescribed fluids per body weight [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

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

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of Minas Gerais

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Isabel Toulson Davisson Correia, Professor of Surgery, Federal University of Minas Gerais
• ClinicalTrials.gov Identifier: NCT03142464
• Other Study ID Numbers: 102908/2015
• First Posted: May 5, 2017
• Last Update Posted: May 8, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maria Isabel Toulson Davisson Correia, Professor of Surgery, Federal University of Minas Gerais: saline solution; laparoscopy; cholecystectomy; outcomes
• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting

Study Results

No Results Posted as of May 8, 2017