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Comparing two methods of sedation using the same drug dexmedetomidine in awake patients undergoing brain surgery

Comparison of target controlled infusion of dexmedetomidine versus conventional dexmedetomidine infusion for awake craniotomy A randomised clinical study - TCIDAC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097921
Enrollment
50
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Target controlled infusion of dexmedetomidine: Hannivoort pharmacokinetic model with effect site concentration of 1 ng/ml titrated to bispectral index 70-80, during cortical brain mapp

Sponsors

Dr Shagun Bhatia Shah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists Physical Status I/II patients, weighing 45-80 kg posted for awake craniotomy

Exclusion criteria

Exclusion criteria: Refusal to give consent, Local Anesthetic Allergy, Raised intracranial pressure, Bradyarrhythmia, Deranged liver function tests

Design outcomes

Primary

MeasureTime frame
Pain Numeric Rating ScaleTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure—

Secondary

MeasureTime frame
Anxiety Numeric Rating Scale (NRS) scoreTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Perfusion IndexTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Observers Assessment of alertness/sedation (OAS/S) scoreTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Heart RateTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Mean Arterial PressureTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Respiratory rateTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Bispectral indexTimepoint: T0 = Baseline T1 = Scalp block T2 = Urinary catheterization T3 = Application of headpins and clamp T4 = Skin Incision T5 = Burr Holes T6 = Dural Incision T7 = Cortical Mapping T8 = Tumour surgery T9 = Dural Closure T10 = Skin closure;Patient Satisfaction with Sedatio—

Countries

India

Contacts

Public ContactDr Shagun Bhatia Shah

Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi

drshagun_2010@rediffmail.com09891769779

Outcome results

None listed

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