Management of Intraoperative Fluids in Ambulatory Surgery
- Conditions
- Ambulatory Surgical ProceduresAnesthesia, GeneralFluid Therapy
- Interventions
- Other: Fluid therapy protocol
- Registration Number
- NCT03193320
- Lead Sponsor
- Policlinica Metropolitana
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 243
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liberal group protocol Fluid therapy 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. PVI-guided group protocol Fluid therapy 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. Restrictive group protocol Fluid therapy 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.
- Primary Outcome Measures
Name Time Method Total volume of fluid infused intraoperatively 0 min after extubation Total volume of ringer lactate solution infused intraoperatively to participants (ml).
Time to discharge 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 Outcome Measures
Name Time Method Significant postoperative nausea and vomiting (PONV) 240 min after extubation (discharge) Presence of significant PONV as determined by a score ≥5 on the scale proposed by Myles SA et al. (BJA 2012)
Postoperative dizziness 30 min after reversal Presence of patient self-reported dizziness in the post-operative period.
Postoperative fatigue 30 min after reversal Presence of patient self-reported fatigue after surgery.
Postoperative thirst 30 min after reversal Presence of patient self-reported thirst after surgery
Trial Locations
- Locations (1)
Policlinica Metropolitana
🇻🇪Caracas, Miranda, Venezuela