Management of Intraoperative Fluids in Ambulatory Surgery (MIFAS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, General; Fluid Therapy; Ambulatory Surgical Procedures
• Intervention / Treatment: Other: Fluid therapy protocol

• Study Type: Interventional
• Enrollment (Anticipated): 243
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renzo G Di Natale, MD; Phone Number: +584122715908; Email: renzogdg@gmail.com

Study Locations

• Venezuela
  • Miranda
    • Caracas, Miranda, Venezuela, 01061
      • Policlinica Metropolitana
      • Contact: Telephone central; Phone Number: +582129080100
      • Principal Investigator: Pascual M Carucci, MD
      • Sub-Investigator: Renzo G Di Natale, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• participants attending the unit for a day surgery procedure
• participants whose surgeries will be performed under general anesthesia
• aged between 18-65 years
• no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation
• patients undergoing procedures which do not require opening of the abdominal or thoracic cavities

Exclusion Criteria:

• ASA score III or higher
• patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)
• known pregnant women
• known kidney disease (or serum creatinine >1.8 mg/dl)
• known liver disease (or AST/ALT >60 U/l)
• known chronic heart failure (determined by a LVEF <55%)
• participants who develop hypotension intraoperatively and do not respond to 4 fluid challenges (1000 ml), requiring aggressive fluid resuscitation OR vasopressors
• estimated blood loss during surgery >250 ml
• development of an adverse reaction to any of the drugs administered during surgery (requiring additional medical management)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liberal group protocol; Fluid loading with 500 ml at induction. Baseline fluid infusion - 8 ml/kg/h. Fluid challenge - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered.	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.
Active Comparator: Restrictive group protocol; No fluid loading at induction. Baseline fluid infusion - 4 ml/kg/h. Fluid challenges - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered.	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.
Experimental: PVI-guided group protocol; No fluid loading at induction. Baseline fluid infusion - 2 ml/kg/h. PVI will be monitored continuously since anesthesia induction. Fluid challenges - if PVI rises >=13 (or MAP falls < 65 mmHg), a fluid challenge will be administered.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of fluid infused intraoperatively	Total volume of ringer lactate solution infused intraoperatively to participants (ml).	0 min after extubation
Time to discharge	Time in hours (h) from anesthesia reversal to fulfillment of patient discharge criteria. Patients will be assessed by an attending nurse every 30 min to assess the fulfillment of these criteria.	240 min after extubation (discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant postoperative nausea and vomiting (PONV)	Presence of significant PONV as determined by a score ≥5 on the scale proposed by Myles SA et al. (BJA 2012)	240 min after extubation (discharge)
Postoperative dizziness	Presence of patient self-reported dizziness in the post-operative period.	30 min after reversal
Postoperative fatigue	Presence of patient self-reported fatigue after surgery.	30 min after reversal
Postoperative thirst	Presence of patient self-reported thirst after surgery	30 min after reversal

Collaborators and Investigators

• Sponsor: Policlinica Metropolitana
• Investigators: Study Director: Pascual M Carucci, MD, Policlinica Metropolitana

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: PVI; plethysmographic variability index
• Other Study ID Numbers: 1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No