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Assessing the effect of drug "dexmedetomidine" during brain surgery on conscious intellectual functions

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium and Cognitive Dysfunction After Brain Surgery - A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054605
Enrollment
550
Registered
2023-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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 Health Condition 2: G938- Other specified disorders of brain

Interventions

Intervention1: Dexmedetomidine: 0.5 µg/kg/h infusion to start with and titrate between 0.1 to 1 µg/kg/h from beginning to end of surgery Control Intervention1: Saline: 0.9% saline as continuous infu

Sponsors

Sriganesh K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients undergoing elective brain surgeries under general anesthesia

Exclusion criteria

Exclusion criteria: Non-brain neurosurgeries, surgery performed awake or with sedation, contraindications to Dexmedetomidine (bradycardia, hypotension, heart block, arrhythmias), children, preexisting cognitive dysfunction, Glasgow Coma Scale (GCS) score < 15, refusal of consent

Design outcomes

Primary

MeasureTime frame
Incidence of Emergence delirium (ED) & postoperative delirium (POD)Timepoint: ED after extubation in post anesthesia care unit POD on first three postoperative days

Secondary

MeasureTime frame
Incidence & severity of acute postoperative pain Timepoint: daily upto 72 h after surgery;Incidence of POCD, Chronic pain, Quality of lifeTimepoint: at 3 and 6 months after surgery on a telephonic interview ;stress biomarkers of surgery (cortisol, glucose, leucocyte count) Timepoint: 1] before and2] after surgery

Countries

India

Contacts

Public ContactSriganesh K

NIMHANS

drsri23@gmail.com09481445949

Outcome results

None listed

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