Management of Intraoperative Fluids in Ambulatory Surgery

Not Applicable

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

• 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

Study Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03
• Study Start: 2020-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 243

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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