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Management of Intraoperative Fluids in Ambulatory Surgery

NCT03193320 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2020-03-03

No results posted yet for this study

Summary

This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed). The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.

Conditions

  • Anesthesia, General
  • Fluid Therapy
  • Ambulatory Surgical Procedures

Interventions

OTHER

Fluid therapy protocol

Only ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.

Sponsors & Collaborators

  • Policlinica Metropolitana

    lead INDUSTRY

Principal Investigators

  • Pascual M Carucci, MD · Policlinica Metropolitana

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-01
Completion
2023-12-01

Countries

  • Venezuela

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193320 on ClinicalTrials.gov