Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

January 22, 2021 updated by: DyAnsys, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 560029
        • National Institute of Mental Health and Neurosciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients of either sex with supratentorial brain lesions who are posted for neurosurgery will be taken as study population. Patients who meet the inclusion criteria and give consent for the study will be included in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain relaxation
Time Frame: 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
2hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DyAnsys, Inc.

Investigators

  • Principal Investigator: Dr. Mathangi Krishnakumar, MBBS,MD,DM, NIMHANS,Bengaluru

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 12, 2019

Primary Completion (ACTUAL)

October 3, 2020

Study Completion (ACTUAL)

October 3, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (ACTUAL)

September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supratentorial Brain Tumors

Clinical Trials on ANSiscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe