Clinical trial NCT03193320: Management of Intraoperative Fluids in Ambulatory Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, General
Fluid Therapy
Ambulatory Surgical Procedures
Keywords: plethysmographic variability index
PVI
Lead sponsor: Policlinica Metropolitana
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Total volume of fluid infused intraoperatively
timeFrame: 0 min after extubation
measure: Time to discharge
timeFrame: 240 min after extubation (discharge)
Secondary outcomes:
measure: Significant postoperative nausea and vomiting (PONV)
timeFrame: 240 min after extubation (discharge)
measure: Postoperative dizziness
timeFrame: 30 min after reversal
measure: Postoperative fatigue
timeFrame: 30 min after reversal
measure: Postoperative thirst
timeFrame: 30 min after reversal
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Policlinica Metropolitana
state: Miranda
Study officials:
affiliation: Policlinica Metropolitana
name: Pascual M Carucci, MD
role: STUDY_DIRECTOR
References: