Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04094974

Enrollment

Registered

2019-09-19

Start date

2019-10-12

Completion date

2020-10-03

Last updated

2021-01-25

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

Conditions

Supratentorial Brain Tumors

Keywords

Heart rate variability,, supratentorial brain tumors, optic nerve sheath diameter

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.

Interventions

DEVICEANSiscope

Heart rate variability will be assessed using ansiscope before surgery

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026