Management of Intraoperative Fluids in Ambulatory Surgery (MIFAS)

Policlinica Metropolitana

Status: Unknown

Conditions: Fluid Therapy; Ambulatory Surgical Procedures; Anesthesia, General

Treatments: Other: Fluid therapy protocol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03193320

1701

Details and patient eligibility

About

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.

Enrollment: 243 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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243 participants in 3 patient groups

Liberal group protocol

Active Comparator group

Description:

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.

Treatment:

Other: Fluid therapy protocol

Restrictive group protocol

Active Comparator group

Description:

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.

Treatment:

Other: Fluid therapy protocol

PVI-guided group protocol

Experimental group

Description:

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.

Treatment:

Other: Fluid therapy protocol