Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors
NCT ID: NCT04094974
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
58 participants
OBSERVATIONAL
2019-10-12
2020-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ANSiscope
Heart rate variability will be assessed using ansiscope before surgery
Eligibility Criteria
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Inclusion Criteria
* ASA(American Society of Anesthesiologists ) I - III
* Patients undergoing surgery for supratentorial tumors
* Glasgow coma scale \> 10
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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DyAnsys, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Mathangi Krishnakumar, MBBS,MD,DM
Role: PRINCIPAL_INVESTIGATOR
NIMHANS,Bengaluru
Locations
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National Institute of Mental Health and Neurosciences
Bengaluru, Karnataka, India
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CS009
Identifier Type: -
Identifier Source: org_study_id
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