Management of Intraoperative Fluids in Ambulatory Surgery

Anesthesia, General Clinical Trial

— MIFAS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03193320
• Other study ID #: 1701
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2020
• Source: Policlinica Metropolitana
• Contact: Renzo G Di Natale, MD
• Phone: +584122715908
• Email: renzogdg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 243
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Anesthesia, General
• Fluid Therapy

Intervention

Other:
• Fluid therapy protocol
Only ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.

Locations

Country	Name	City	State
Venezuela	Policlinica Metropolitana	Caracas	Miranda

Sponsors (1)

Lead Sponsor	Collaborator
Policlinica Metropolitana

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of fluid infused intraoperatively	Total volume of ringer lactate solution infused intraoperatively to participants (ml).	0 min after extubation
Primary	Time to 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.	240 min after extubation (discharge)
Secondary	Significant postoperative nausea and vomiting (PONV)	Presence of significant PONV as determined by a score =5 on the scale proposed by Myles SA et al. (BJA 2012)	240 min after extubation (discharge)
Secondary	Postoperative dizziness	Presence of patient self-reported dizziness in the post-operative period.	30 min after reversal
Secondary	Postoperative fatigue	Presence of patient self-reported fatigue after surgery.	30 min after reversal
Secondary	Postoperative thirst	Presence of patient self-reported thirst after surgery	30 min after reversal