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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 243
- Locations
- 2
- Primary Endpoint
- Total volume of fluid infused intraoperatively
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants will be under general anesthesia during the interventions. Outcome assessors (nurses) will be blinded to the treatment provided in the operating rooms
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Total volume of fluid infused intraoperatively
Time Frame: 0 min after extubation
Total volume of ringer lactate solution infused intraoperatively to participants (ml).
Time to discharge
Time Frame: 240 min after extubation (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.
Secondary Outcomes
- 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)
Investigators
Renzo Di Natale
Medical doctor (MD)
Policlinica Metropolitana