Anesthesia, General Clinical Trial
— MIFASOfficial 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
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.
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) |
Country | Name | City | State |
---|---|---|---|
Venezuela | Policlinica Metropolitana | Caracas | Miranda |
Lead Sponsor | Collaborator |
---|---|
Policlinica Metropolitana |
Venezuela,
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 |
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