Skip to main content
OpenTrials
Completed

NCT Number: NCT04094974

Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Supratentorial Brain Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, 560029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANSiscope

Device

Heart rate variability will be assessed using ansiscope before surgery

Primary outcomes

  1. Brain relaxation

    Time frame: 2hours

    • Tight Brain-the brain surface is jutting out or expanding beyond the craniotomy margins, brain pulsations are not clearly defined.
    • Brain surface at level of craniotomy margins, Brain pulsations faintly observed
    • Brain surface just below the surface of craniotomy margin. Brain pulsations well seen.
    • 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 outcomes

  1. Hemodynamic Measurement-Heartrate

    Time frame: 2hours

    The change in hemodynamic variable heart rate in beats per minute will be measured through the study period

  2. Hemodynamic Measurement-Bloodpressure

    Time frame: 2hours

    The change in hemodynamic variable blood pressure in mmHg will be measured through the study period

Sponsors and collaborators

Lead sponsor

DyAnsys, Inc.

Industry

Registry information

Official study title

The Usefulness of the Combination of Preoperative Assessment of Optic Nerve Sheath Diameter and Heart Rate Variability to Predict Intraoperative Brain Condition in Patients With Supratentorial Tumors

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2019
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.