Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

NCT04094974 | Completed DMC

• 1 other identifier: CS009
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Supratentorial Brain Tumors

Keywords

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

Outcome Measures

Primary Outcomes (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

  2hours

Secondary Outcomes (2)

• Hemodynamic Measurement-Heartrate

  2hours

• Hemodynamic Measurement-Bloodpressure

  2hours

Interventions

ANSiscope DEVICE

Heart rate variability will be assessed using ansiscope before surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• DyAnsys, Inc.: lead

Study Sites (1)

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, 560029, India

Location

Related Publications (9)

• 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.

  PMID: 27121854 BACKGROUND

• 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.

  PMID: 15481716 BACKGROUND

• 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.

  PMID: 30019201 BACKGROUND

• 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.

  PMID: 29472865 BACKGROUND

• 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.

  PMID: 19051691 BACKGROUND

• 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.

  PMID: 28471773 BACKGROUND

• 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.

  PMID: 29151668 BACKGROUND

• 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.

  PMID: 26571037 BACKGROUND

• 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.

  PMID: 8672261 BACKGROUND

Study Officials

• Dr. Mathangi Krishnakumar, MBBS,MD,DM

  NIMHANS,Bengaluru

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 19, 2019
• Study Start: October 12, 2019
• Primary Completion: October 3, 2020
• Study Completion: October 3, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)