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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03193320 |
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Date of registration:
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15/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Management of Intraoperative Fluids in Ambulatory Surgery
MIFAS |
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Scientific title:
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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 |
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Date of first enrolment:
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December 1, 2020 |
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Target sample size:
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243 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03193320 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Renzo G Di Natale, MD |
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Address:
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Telephone:
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+584122715908 |
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Email:
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renzogdg@gmail.com |
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Affiliation:
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Name:
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Telephone central |
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Address:
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Telephone:
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+582129080100 |
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Email:
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Affiliation:
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Name:
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Pascual M Carucci, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Policlinica Metropolitana |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ambulatory Surgical Procedures
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Anesthesia, General
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Fluid Therapy
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Intervention(s)
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Other: Fluid therapy protocol
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Primary Outcome(s)
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Time to discharge
[Time Frame: 240 min after extubation (discharge)]
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Total volume of fluid infused intraoperatively
[Time Frame: 0 min after extubation]
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Secondary Outcome(s)
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Postoperative dizziness
[Time Frame: 30 min after reversal]
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Postoperative thirst
[Time Frame: 30 min after reversal]
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Postoperative fatigue
[Time Frame: 30 min after reversal]
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Significant postoperative nausea and vomiting (PONV)
[Time Frame: 240 min after extubation (discharge)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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