Management of Intraoperative Fluids in Ambulatory Surgery

NCT03193320 | Unknown

• 1 other identifier: 1701
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

plethysmographic variability index; PVI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Significant postoperative nausea and vomiting (PONV)

  240 min after extubation (discharge)

• Postoperative dizziness

  30 min after reversal

• Postoperative fatigue

  30 min after reversal

• Postoperative thirst

  30 min after reversal

Study Arms (3)

Liberal group protocol

ACTIVE COMPARATOR

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

Restrictive group protocol

ACTIVE COMPARATOR

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

PVI-guided group protocol

EXPERIMENTAL

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

Interventions

Fluid therapy protocol OTHER

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.

Liberal group protocol; PVI-guided group protocol; Restrictive group protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Policlinica Metropolitana: lead

Study Sites (1)

Policlinica Metropolitana

Caracas, Miranda, 01061, Venezuela

Location

Study Officials

• Pascual M Carucci, MD

  Policlinica Metropolitana

  STUDY DIRECTOR

Central Study Contacts

Renzo G Di Natale, MD

CONTACT

+584122715908; renzogdg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be under general anesthesia during the interventions. Outcome assessors (nurses) will be blinded to the treatment provided in the operating rooms
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor (MD)

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 20, 2017
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

VE (1)