CTRI

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CTRI Number

CTRI/2025/11/097921 [Registered on: 24/11/2025] Trial Registered Prospectively

Last Modified On:

21/11/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

TCIDAC

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Shagun Bhatia Shah
Designation	Senior Consultant Anaesthesiologist
Affiliation	Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi
Address	Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini DELHI 110085 India North West DELHI 110085 India
Phone	09891769779
Fax
Email	drshagun_2010@rediffmail.com

Details of Contact Person
Scientific Query

Name	Dr Shagun Bhatia Shah
Designation	Senior Consultant Anaesthesiologist
Affiliation	Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi
Address	Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini DELHI 110085 India North West DELHI 110085 India
Phone	09891769779
Fax
Email	drshagun_2010@rediffmail.com

Details of Contact Person
Public Query

Name	Dr Shagun Bhatia Shah
Designation	Senior Consultant Anaesthesiologist
Affiliation	Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi
Address	Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini DELHI 110085 India North West DELHI 110085 India
Phone	09891769779
Fax
Email	drshagun_2010@rediffmail.com

Source of Monetary or Material Support

Rajiv Gandhi Cancer Institute and Research Centre, Rohini, Delhi.

Primary Sponsor

Name	Dr Shagun Bhatia Shah
Address	Senior Consultant Room, Ninth Floor, Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shagun Bhatia Shah	Rajiv Gandhi Cancer Institute and Research Centre	Operation Theatre no:14;Department of Anaesthesia;Operation Theatre Division; Ninth Floor ;New Building; Sector-5;Rohini;Delhi-11008 5 North West DELHI	09891769779 drshagun_2010@rediffmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre, Delhi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional dexmedetomidine infusion	Loading dose of 1 microgram/kg over 10 minutes followed by a maintenance infusion of 0.2-0.8 microgram/kg/h, titrated to bispectral index of 70-80 during cortical brain mapping
Intervention	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 mapping

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	American Society of Anesthesiologists Physical Status I/II patients, weighing 45-80 kg posted for awake craniotomy

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Pain Numeric Rating Scale	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 Outcome

Outcome	TimePoints
Anxiety Numeric Rating Scale (NRS) score	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 Index	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) score	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 Rate	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 Pressure	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 rate	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 index	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 Sedation Instrument (PSSI)	30 min after surgery
Clinician Satisfaction with Sedation Instrument (CSSI)	30 min after surgery
Trieger Test	30 min after surgery

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

05/12/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="10"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [drshagun_2010@rediffmail.com].

For how long will this data be available start date provided 20-04-2027 and end date provided 20-04-2030?
Response - Beginning 9 months and ending 36 months following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

This prospective, interventional, parallel-arm, single-centric randomised controlled study aims to compare the effectiveness of the Hannivoort pharmacokinetic model for target-controlled infusion of dexmedetomidine with the conventional intravenous dexmedetomidine infusion for sedoanalgesia in patients undergoing awake craniotomy. It shall include 50 adult ASA I-II patients of either sex aged 18-70 years, weighing 45-80kg. Exclusion criteria comprise refusal to give consent, local anaesthetic allergy, raised intracranial pressure, bradyarrhythmias, and deranged hepatic function. The study shall be conducted at Rajiv Gandhi Cancer Institute and Research Centre, Delhi. The patients shall be randomly allocated to two groups: conventional dexmedetomidine infusion group (Group C; n = 25), and target controlled infusion of dexmedetomidine group (Group T; n = 25). Our primary outcome measure would be the pain numeric rating scale (NRS), measured at the time of scalp block, urinary catheter placement, headpins application, skin incision, burr holes, dural incision, cortical mapping, tumour resection, dural closure and skin closure. Our secondary outcome measures shall be anxiety NRS, perfusion index, heart rate, mean arterial pressure, respiratory rate, bispectral index, and observer’s assessment of anxiety/sedation score measured at the above time points. We shall also measure the patient satisfaction score, clinician satisfaction score, and Trieger test score 30 minutes after completion of surgery.