Preventing Low Blood Pressure During Emergency Brain Surgery: A Comparison With and Without a Prediction Tool

Comparison of burden of Intraoperative Hypotension in patients undergoing Emergency Surgeries for Acute Traumatic Brain Injury with and without using Hypotension Prediction Index Tool - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112936

Enrollment

180

Registered

2026-06-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S062- Diffuse traumatic brain injury

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years of either gender 2. Patients presenting with GCS 4 to 13 3. Surgeries performed in supine position

Exclusion criteria

Exclusion criteria: 1. Significant hypotension SBP less than 90 mmHg before the surgery 2. Pre existing cardiac disease like CHF, IHD, uncontrolled hypertension, arrhythmias, cardiac shunts, etc. 3. Pregnant women 4. Refusal of consent 5. Technical issues with arterial BP monitoring 6. Patients undergoing bifrontal surgery where depth of anesthesia monitoring is not possible

Design outcomes

Primary

Measure	Time frame
To compare the Time Weighted Average of intraoperative hypotension between the HPI group and the conventional groupTimepoint: Baseline followed by every minute till the end of the case	—

Secondary

Measure	Time frame
To compare the duration, incidence, severity, and time period of intraoperative hypotension between the groups.Timepoint: Baseline followed by every minute till the end of the case;To compare the peri-operative outcomes including vasopressor use, myocardial ischemia, acute kidney injury, duration of ICU stay and hospital stay and functional outcome of the patient at hospital discharge and at 3 months between the two groupsTimepoint: Baseline followed by every minute till the end of the case, duration in hospital, at discharge and 3 months after discharge	—

Measure

Time frame

To compare the duration, incidence, severity, and time period of intraoperative hypotension between the groups.Timepoint: Baseline followed by every minute till the end of the case;To compare the peri-operative outcomes including vasopressor use, myocardial ischemia, acute kidney injury, duration of ICU stay and hospital stay and functional outcome of the patient at hospital discharge and at 3 months between the two groupsTimepoint: Baseline followed by every minute till the end of the case, duration in hospital, at discharge and 3 months after discharge

—

Countries

India

Contacts

Public ContactDr Sriganesh Kamath

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES

drsri23@gmail.com9481445949

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026