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study the effect of dexmedetomidine drug in preventing confusional state and agitation that occurs in patients undergoing brain surgery under general anaesthesia.

Comparison of the effect of intraoperative infusion of dexmedetomidine on emergence agitation and delirium in children undergoing craniotomy with total intravenous anaesthesia (TIVA) with propofol ââ?¬â?? A randomized controlled clinical trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037735
Enrollment
80
Registered
2021-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: dexmedetomidine infusion: Intervention arm will receive an infusion of Propofol 150-250 mcg/kg/hr, Fentanyl 1-2 mcg/kg/hr titrated to a BIS of 40-60 without volatile anaesthetic. It wil

Sponsors

Institutional Review BoardChristian Medical CollegeVellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and 2 Paediatric age group patients planned for craniotomy under general anaesthesia will be recruited for the study.

Exclusion criteria

Exclusion criteria: 1)ASA 3 and above. 2)Known allergy to study drugs. 3)History of renal disease-age appropriate e-GFR criteria 4)History of liver disease. 5)Psychiatric illness 6)Heart block, known case of seizure disorder coming for seizure surgery 7)Patient refusal 8)GCS

Design outcomes

Primary

MeasureTime frame
Emergence Delirium as assessed by the PAED scaleTimepoint: 7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours—

Secondary

MeasureTime frame
1)Emergence Agitation as assessed by Watcha, Richmondââ?¬â?¢s agitation sedation scale 2.Intraoperative and Postoperative haemodynamics 3.Recovery characteristics 4.Postoperative Analgesia Timepoint: 7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours—

Countries

India

Contacts

Public ContactDr Georgene singh

Christian Medical College

georgene@cmcvellore.ac.in9443292504

Outcome results

None listed

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