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Management of Intraoperative Fluids in Ambulatory Surgery (MIFAS)

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ClinicalTrials.gov Identifier: NCT03193320
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Renzo Di Natale, 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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Fluid Therapy Ambulatory Surgical Procedures Other: Fluid therapy protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be under general anesthesia during the interventions. Outcome assessors (nurses) will be blinded to the treatment provided in the operating rooms
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 17, 2020
Estimated Primary Completion Date : December 17, 2020
Estimated Study Completion Date : December 17, 2020

Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Total volume of fluid infused intraoperatively [ Time Frame: 0 min after extubation ]
    Total volume of ringer lactate solution infused intraoperatively to participants (ml).

  2. Time to discharge [ Time Frame: 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 :
  1. Significant postoperative nausea and vomiting (PONV) [ Time Frame: 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)

  2. Postoperative dizziness [ Time Frame: 30 min after reversal ]
    Presence of patient self-reported dizziness in the post-operative period.

  3. Postoperative fatigue [ Time Frame: 30 min after reversal ]
    Presence of patient self-reported fatigue after surgery.

  4. Postoperative thirst [ Time Frame: 30 min after reversal ]
    Presence of patient self-reported thirst after surgery



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193320


Contacts
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Contact: Renzo G Di Natale, MD +584122715908 renzogdg@gmail.com

Locations
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Venezuela
Policlinica Metropolitana Not yet recruiting
Caracas, Miranda, Venezuela, 01061
Contact: Telephone central    +582129080100      
Principal Investigator: Pascual M Carucci, MD         
Sub-Investigator: Renzo G Di Natale, MD         
Sponsors and Collaborators
Policlinica Metropolitana
Investigators
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Study Director: Pascual M Carucci, MD Policlinica Metropolitana

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Responsible Party: Renzo Di Natale, Medical doctor (MD), Policlinica Metropolitana
ClinicalTrials.gov Identifier: NCT03193320     History of Changes
Other Study ID Numbers: 1701
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Renzo Di Natale, Policlinica Metropolitana:
plethysmographic variability index
PVI