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Can Pupil Size and Heart Rate Help Monitor Sedation in Patients Given Dexmedetomidine

Exploring Heart Rate Variability and Pupillometry as Predictors of Sedation Depthin Dexmedetomidine Sedation in Non-Operating Room Anaesthesia (NORA) Settings - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/089550
Enrollment
100
Registered
2025-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system

Interventions

Intervention1: Nil: Nil

Sponsors

Shweta Suresh Naik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Paediatric and Adults aged 2 to 70 years. 2. Scheduled for a procedure requiring sedation with dexmedetomidine in a NORA setting.

Exclusion criteria

Exclusion criteria: 1. Patients with pre-existing cardiovascular, neurological, or ocular conditions that might interfere with accurate HRV or pupillometry measurements. 2. Patients with a history of severe allergic reactions to dexmedetomidine or contraindications to its use. 3. Patients currently on medications known to significantly alter autonomic function. 4. Refusal of consent 5. Change in sedation protocol from dexmedetomidine

Design outcomes

Primary

MeasureTime frame
1.To evaluate the changes in HRV as a response to dexmedetomidine administration in NORA settingsTimepoint: baseline, start of sedation, end of sedation

Secondary

MeasureTime frame
2. To correlate HRV changes with clinically assessed sedation levels using the Richmond Agitation-Sedation Scale (RAAS).Timepoint: baseline, start of sedation, end of sedation

Countries

India

Contacts

Public ContactShweta Suresh Naik

National Institute of Mental Health and Neurosciences

neurodocms@gmail.com9986308719

Outcome results

None listed

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