Clinical trial NCT04094974: Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supratentorial Brain Tumors
Keywords: Heart rate variability,
supratentorial brain tumors
optic nerve sheath diameter
Lead sponsor: DyAnsys, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Brain relaxation
timeFrame: 2hours
Secondary outcomes:
measure: Hemodynamic Measurement-Heartrate
timeFrame: 2hours
measure: Hemodynamic Measurement-Bloodpressure
timeFrame: 2hours
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: National Institute of Mental Health and Neurosciences
state: Karnataka
Study officials:
affiliation: NIMHANS,Bengaluru
name: Dr. Mathangi Krishnakumar, MBBS,MD,DM
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
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