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Supratentorial Brain TumorsNCT04094974

Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

An observational study of Supratentorial Brain Tumors, run by DyAnsys, Inc. at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Supratentorial Brain Tumors
What is being tested?
ANSiscope
Type of treatment
Medical device
How many people
58 participants
Where
1 siteIndia
Study dates
12 Oct 2019to 3 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Head injury
  • Patient on beta blockers, ACE(angiotensin-converting-enzyme) inhibitors, Clonidine
  • Diabetes mellitus for more than 5 years

Trial locations and contacts

1 site in 1 country.

India1 site

  • National Institute of Mental Health and Neurosciences

    Bengaluru, Karnataka, 560029

Other trials in India

About this study

Official 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

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

Read the 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.

Being tested
ANSiscope
Keywords
Heart rate variability,, supratentorial brain tumors, optic nerve sheath diameter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANSiscopeDevice

    Heart rate variability will be assessed using ansiscope before surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brain relaxation

    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

    Measured: 2hours

Secondary outcomes (2)

  1. Hemodynamic Measurement-Heartrate

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

    Measured: 2hours

  2. Hemodynamic Measurement-Bloodpressure

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

    Measured: 2hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start12 Oct 2019
  3. Primary completion3 Oct 2020
  4. Study completion3 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094974
Sponsor's protocol ID
CS009
Status last verified
Jan 2021
First submitted
13 Sep 2019
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li J, Gelb AW, Flexman AM, Ji F, Meng L. Definition, evaluation, and management of brain relaxation during craniotomy. Br J Anaesth. 2016 Jun;116(6):759-69. doi: 10.1093/bja/aew096. Epub 2016 Apr 27.

    PubMed 27121854

  • Rasmussen M, Bundgaard H, Cold GE. Craniotomy for supratentorial brain tumors: risk factors for brain swelling after opening the dura mater. J Neurosurg. 2004 Oct;101(4):621-6. doi: 10.3171/jns.2004.101.4.0621.

    PubMed 15481716

  • Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.

    PubMed 30019201

  • Schmidt EA, Despas F, Pavy-Le Traon A, Czosnyka Z, Pickard JD, Rahmouni K, Pathak A, Senard JM. Intracranial Pressure Is a Determinant of Sympathetic Activity. Front Physiol. 2018 Feb 8;9:11. doi: 10.3389/fphys.2018.00011. eCollection 2018.

    PubMed 29472865

  • Furgala A, Madroszkiewicz D, Madroszkiewicz E, Goscinski I, Kolasinska-Kloch W, Moskala M, Thor PJ. Autonomic system disturbances in patients with increased intracranial pressure caused by brain tumors evaluated by heart rate variability. Folia Med Cracov. 2007;48(1-4):35-44.

    PubMed 19051691

  • Jadhav T, Sriganesh K, Thirthalli J, Reddy KRM, Venkataramaiah S, Philip M, Naveen Kumar C, Armugham SS. Effect of Atropine Premedication on Cardiac Autonomic Function During Electroconvulsive Therapy: A Randomized Crossover Study. J ECT. 2017 Sep;33(3):176-180. doi: 10.1097/YCT.0000000000000417.

    PubMed 28471773

  • Weickenmeier J, Saze P, Butler CAM, Young PG, Goriely A, Kuhl E. Bulging brains. J Elast. 2017 Dec;129(1-2):197-212. doi: 10.1007/s10659-016-9606-1. Epub 2016 Oct 24.

    PubMed 29151668

  • Hernandez-Palazon J, Fuentes-Garcia D, Domenech-Asensi P, Piqueras-Perez C, Falcon-Arana L, Burguillos-Lopez S. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation during elective supratentorial craniotomy. Br J Neurosurg. 2016;30(1):70-5. doi: 10.3109/02688697.2015.1109061. Epub 2015 Nov 16.

    PubMed 26571037

  • Cold GE, Tange M, Jensen TM, Ottesen S. "Subdural' pressure measurement during craniotomy. Correlation with tactile estimation of dural tension and brain herniation after opening of dura. Br J Neurosurg. 1996 Feb;10(1):69-75. doi: 10.1080/02688699650040548.

    PubMed 8672261

Questions about this trial

What is this clinical trial studying?

An observational study of Supratentorial Brain Tumors, run by DyAnsys, Inc. at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain relaxation (time frame: 2hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04094974, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.

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