Health Condition 1: C724- Malignant neoplasm of acoustic nerve Health Condition 2: C719- Malignant neoplasm of brain, unspecified Health Condition 3: C700- Malignant neoplasm of cerebral meninges Health Condition 4: O- Medical and Surgical
Conditions
Interventions
Intervention1: Hypotension Prediction Index software of Edward Lifesciences EV-1000: Patients in HPI group will have an additional Acumen FlorTrac transducer connected to an EV-1000 monitor with the H
Sponsors
NIMHANS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 65 years of either gender. 2. American Society of Anesthesiologists physical status (ASA-PS) I and II patients. 3. Undergoing elective surgery for excision of brain tumors with or without intraoperative neuromonitoring. 4. With brain tumors of size more than 4 cms. 5. Anticipated intraoperative bleeding of more than 500mL.
Exclusion criteria
Exclusion criteria: 1. Significant hypotension before surgey. 2. With known left or right cardiac failure. 3. With significant hypertension. 4. Arrhythmias (Atrial fibrillation), cardiac shunts, severe aortic stenosis. 5. Emergency surgery. 6. Surgery done in sitting position. 7. Pregnant women. 8. Refuse to give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of intraoperative hypotension in both the HPI group and the conventional groupTimepoint: Baseline followed by every minute till the end of the case. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the amount of intraoperative crystalloid & collloids, erythrocyte transfusions, cumulative dose of the vasoactive medications, anesthetic & analgesics, depth of anaesthesia values, blood loss & urine output between the two groupsTimepoint: Baseline followed by every minute till the end of the case.;Compare the outcome measures- intraoperative vasopressor use, intraoperative myocardial ischemia ( ST segment values more than or less than 2mm), acute kidney injury ( changes in serum creatinine by more than 0.3mg% as per AKIN criteria), emergence ( Riker sedation agitation scale) & postoperative delirium ( confusion assessment method), new onset motor deficits ( perioperative stroke), length of ICU stay & duration of hospital stay.Timepoint: Baseline followed by every minute till the end of the case.;Incidence of intraoperative hypotension, defined as the number of hypotensive events. A hypotensive event is defined as reduction of mean arterial pressure to less than 65 mm Hg for at least 1min. The hypotensive event will end when the MAP value is normalised.Timepoint: Baseline followed by every minute till the end of the case.;Severity of hypotension by calculating the time weighted average of intraoperative hypotension below 60mm Hg of MAP & below 55mm Hg of MAP between the two groupsTimepoint: Baseline followed by every minute till the end of the case.;Time Weighted Average of intraoperative hypotension defined as the depth of hypotension with a fall in mean arterial pressure to less than 65mm Hg multiplied by the time spend with mean arterial pressure of less than 65mm Hg divided by the total duration of surgeryTimepoint: Baseline followed by every minute till the end of the case.;To calculate the cost effectiveness/financial burden with the use of HPI indexTimepoint: Baseline followed by every minute till the end of the case. | — |
Countries
India
Contacts
Public ContactDr Sriganesh K
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Outcome results
None listed