Supratentorial Brain Tumors Clinical Trial
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
| NCT number | NCT04094974 |
| Other study ID # | CS009 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 12, 2019 |
| Est. completion date | October 3, 2020 |
| Verified date | January 2021 |
| Source | DyAnsys, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | October 3, 2020 |
| Est. primary completion date | October 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| India | National Institute of Mental Health and Neurosciences | Bengaluru | Karnataka |
| Lead Sponsor | Collaborator |
|---|---|
| DyAnsys, Inc. |
India,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brain relaxation | Tight Brain-the brain surface is jutting out or expanding beyond the craniotomy margins, brain pulsations are not clearly defined.
Brain surface at level of craniotomy margins, Brain pulsations faintly observed Brain surface just below the surface of craniotomy margin. Brain pulsations well seen. 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 | Hemodynamic Measurement-Heartrate | The change in hemodynamic variable heart rate in beats per minute will be measured through the study period | 2hours | |
| Secondary | Hemodynamic Measurement-Bloodpressure | The change in hemodynamic variable blood pressure in mmHg will be measured through the study period | 2hours |