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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal group protocol | Active Comparator | 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. |
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| Restrictive group protocol | Active Comparator | 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. |
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| PVI-guided group protocol | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid therapy protocol | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total volume of fluid infused intraoperatively | Total volume of ringer lactate solution infused intraoperatively to participants (ml). | 0 min after extubation |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Postoperative dizziness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renzo G Di Natale, MD | Contact | +584122715908 | renzogdg@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pascual M Carucci, MD | Policlinica Metropolitana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinica Metropolitana | Caracas | Miranda | 01061 | Venezuela |
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Participants will be under general anesthesia during the interventions. Outcome assessors (nurses) will be blinded to the treatment provided in the operating rooms
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Presence of patient self-reported dizziness in the post-operative period.
| 30 min after reversal |
| Postoperative fatigue | Presence of patient self-reported fatigue after surgery. | 30 min after reversal |
| Postoperative thirst | Presence of patient self-reported thirst after surgery | 30 min after reversal |