Clinical trial · Observational
Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors
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
NCT04094974CI-TRIAL-00049585completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Supratentorial Brain Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANSiscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Brain relaxation
- timeFrame
- 2hours
- description
- 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 (2)
- measure
- Hemodynamic Measurement-Heartrate
- timeFrame
- 2hours
- description
- The change in hemodynamic variable heart rate in beats per minute will be measured through the study period
- measure
- Hemodynamic Measurement-Bloodpressure
- timeFrame
- 2hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDLi 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
- BACKGROUNDRasmussen 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
- BACKGROUNDRobba 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
- BACKGROUNDSchmidt 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
- BACKGROUNDFurgala 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
- BACKGROUNDJadhav 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
- BACKGROUNDWeickenmeier 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.