Management of Intraoperative Fluids in Ambulatory Surgery

NCT ID: NCT03193320

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-12-01

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.

Conditions

Anesthesia, General; Fluid Therapy; Ambulatory Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Liberal group 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.

Group Type: ACTIVE_COMPARATOR

Fluid therapy protocol

Intervention Type: OTHER

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.

Restrictive group 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.

Group Type: ACTIVE_COMPARATOR

Fluid therapy protocol

Intervention Type: OTHER

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.

PVI-guided group 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.

Group Type: EXPERIMENTAL

Fluid therapy protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Policlinica Metropolitana

INDUSTRY

Sponsor Role: lead

Responsible Party

Renzo Di Natale

Medical doctor (MD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pascual M Carucci, MD

Role: STUDY_DIRECTOR

Policlinica Metropolitana

Locations

Policlinica Metropolitana

Caracas, Miranda, Venezuela

Countries

Venezuela

Central Contacts

Renzo G Di Natale, MD

Role: CONTACT

renzogdg@gmail.com

+584122715908

Facility Contacts

Telephone central

Role: primary

+582129080100

Other Identifiers

1701

Identifier Type: -

Identifier Source: org_study_id