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comparision of one anaesthetic drug with another on its effect of blood flow and oxygenation of brain in patients undergoing brain surgery for intracranial space occupying lesions: A Randomized Double-Blinded Controlled Trial

Comparison of the effect of ketofol versus propofol on cerebral blood flow and cerebral oxygenation in patients undergoing neurosurgery for supratentorial intracranial space occupying lesions: A Randomized Double-Blinded Controlled Trial - NIL

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075063
Enrollment
44
Registered
2024-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: D430- Neoplasm of uncertain behavior ofbrain, supratentorial

Interventions

Intervention1: Ketofol: Ketamine+Propofol as anaesthetic agent.50 ml syringe containing 40 ml of propofol (10mg/ml) and 8 ml of ketamine (10 mg/ml). The dose will be titrated according to neuromonitor

Sponsors

Sree Chitra Tirunal Institute for Medical Sciences and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consenting adult patients aged 18-60 years undergoing supratentorial intracranial space-occupying lesion surgery in neurosurgery operation theatre at Sree Chitra Tirunal Institute for Medical Sciences and Technology. 1. ASA (American Society of Anaesthesiologists) classes 1 and 2 2. GCS 15 before the surgery

Exclusion criteria

Exclusion criteria: Minor, pregnant woman, neonates and patients incompetent to give consent will not be included in the study

Design outcomes

Primary

MeasureTime frame
To compare the cerebral blood flow using TCD and cerebral oxygenation using NIRS between the two groupsTimepoint: a) Baseline-Before induction of anaesthesia (T0) b) 15mins Post Induction (T1)

Secondary

MeasureTime frame
intraoperative haemodynamics, brain bulge, use of opioids and outcome at the time of discharge between the two groups.Timepoint: Baseline-T0, 15 mins Post-induction-T1, Head pin application-T2, Burr hole-T3, ICP measurement-T4, Craniotomy-T5, Bone flap removal-T6, Dural opening-T7, Tumour excision-T8, Dural closure-T9, Muscle suture-T10, Skin suture-T11.

Countries

India

Contacts

Public ContactNaveen Vivek S

Sree Chitra Tirunal Institute For Medical Sciences and Technology

drrpcs@gmail.com9855746254

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026