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Comparing treatment to control brain pressure based on changes in blood and oxygen supply under anaesthesia in patients undergoing brain tumor surgery

Comparison of transcranial doppler (TCD)- and Near infrared spectroscopy (NIRS)-guided optimization of intracranial dynamics versus standard management for brain relaxation in supratentorial tumor surgery: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110409
Enrollment
60
Registered
2026-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Algorithmic based management using transcranial doppler (TCD) and Near infrared spectroscopy (NIRS): Early institution of brain pressure lowering methods guided by transcranial doppler

Sponsors

Nirupa Elizabeth Koshy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Supratentorial intraxial space occupying lesion surgery. 2.Preoperative imaging showing features of raised intracranial pressure

Exclusion criteria

Exclusion criteria: 1.Posterior fossa or skull base tumors. 2.Extraaxial lesions. 3.Inadequate TCD window. 4.Severe cardiopulmonary disease. 5.Significant anemia. 6.Prior craniotomy or skull defect near the insonation site. 7.Pregnancy. 8.Refusal to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
To compare the brain relaxation score between the standard group and the intervention groupTimepoint: Measured once at baseline during surgery after the covering of the brain is exposed.

Secondary

MeasureTime frame
To compare rates of emergence agitation & postoperative delirium between groups.Timepoint: Immediate Postoperative;To compare the requirements of ICP reduction strategies between groups.Timepoint: End of surgery;To compare ICU & hospital length of stay between groups.Timepoint: At hospital discharge;To compare postoperative complications in terms of new onset neurological deficits & CT findings (edema, midline shift, infarct, hemorrhage)Timepoint: Post operative day 3

Countries

India

Contacts

Public ContactSudhir V

National Institute of Mental Health and Neurosciences

vsudhir77@gmail.com9900793108

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026