Skip to main content
Clinical Trials/NCT04094974
NCT04094974
Completed
Not Applicable

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

DyAnsys, Inc.1 site in 1 country58 target enrollmentOctober 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Supratentorial Brain Tumors
Sponsor
DyAnsys, Inc.
Enrollment
58
Locations
1
Primary Endpoint
Brain relaxation
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2019
End Date
October 3, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Hemodynamic Measurement-Heartrate(2hours)
  • Hemodynamic Measurement-Bloodpressure(2hours)

Study Sites (1)

Loading locations...

Similar Trials