Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

Completed

• Conditions: Supratentorial Brain Tumors

• Registration Number: NCT04094974
• Lead Sponsor: DyAnsys, Inc.

Brief Summary

This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.

Detailed Description

Patients undergoing brain surgery for treatment of brain tumors will be studied to determine the relationship between heart rate variability and intraoperative brain relaxation conditions.

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2019-10-12
• Primary Completion: 2020-10-03
• Study Completion: 2020-10-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Patient aged 18 to 75 years
• ASA(American Society of Anesthesiologists ) I - III
• Patients undergoing surgery for supratentorial tumors
• Glasgow coma scale > 10

Exclusion Criteria

• Patient aged below 18 and above 75 years.
• Pregnancy
• ASA(American Society of Anesthesiologists) IV-V
• Previous cranial surgery
• Morbid obesity ( BMI>40)
• Ocular injury/ Glaucoma
• Head injury
• Patient on beta blockers, ACE(angiotensin-converting-enzyme) inhibitors, Clonidine
• Diabetes mellitus for more than 5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain relaxation	2hours	1. Tight Brain-the brain surface is jutting out or expanding beyond the craniotomy margins, brain pulsations are not clearly defined.; 2. Brain surface at level of craniotomy margins, Brain pulsations faintly observed; 3. Brain surface just below the surface of craniotomy margin. Brain pulsations well seen.; 4. Brain surface well below the surface of craniotomy margin, well retracted in to the cranial cavity with good brain pulsations.Brain relaxation score will me measured only once. There is no follow up

Secondary Outcome Measures

Name	Time	Method
Hemodynamic Measurement-Heartrate	2hours	The change in hemodynamic variable heart rate in beats per minute will be measured through the study period
Hemodynamic Measurement-Bloodpressure	2hours	The change in hemodynamic variable blood pressure in mmHg will be measured through the study period

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bengaluru, Karnataka, India