NCT03193320

Management of Intraoperative Fluids in Ambulatory Surgery

Intraoperative Fluid Therapy Management in Low-risk Patients Under General Anesthesia- a Randomized Controlled Trial Comparing Liberal, Restrictive and Pleth Variability Index (PVI)-Guided Fluid Administration in a Day Surgery Setting

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Policlinica Metropolitana · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2023-12-01
• First posted: 2017-06-20
• Last updated: 2020-03-03

Locations

1 site across 1 country: Venezuela