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Use of brain activity monitoring device (FNIRS) to evaluate pain response and change in brain oxyhemoglobin level in ICU patients on Ventilator receiving Dexmedetomidine and Fentanyl infusion for sedation

FNIRS based evaluation of nociception under Dexmedetomidine versus Fentanyl infusion in mechanically ventilated patients in intensive care unit- a randomised controlled trial - FEND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097605
Enrollment
150
Registered
2025-11-18
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: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: Analgesia based sedation using Dexmedetomidine: Intubated and Mechanically ventilated patients in ICU will receive intravenous Dexmedetomidine infusion at 0.2-0.7 mcg/kg/hours for durat

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years 2. Admitted to the ICU within 24 hours of intubation and mechanical ventilation 3. Intubated in ICU

Exclusion criteria

Exclusion criteria: 1. Patient receiving other sedative analgesic drugs (Benzodiazepine, Propofol) 2. Life-threatening bleeding, the presence of hemorrhagic shock, as judged by research or treating clinicians 3. Burns, Pregnancy 4. Referral from or treated at other healthcare facilities 5. Withdrawal of consent

Design outcomes

Primary

MeasureTime frame
To compare concentration changes in Oxyhemoglobin at somatosensory cortex during nociceptive stimuli (endotracheal suctioning) in mechanically ventilated patients in intensive care unit receiving either dexmedetomidine of fentanyl for analgesia-based sedation.Timepoint: Day 1

Secondary

MeasureTime frame
1. Assess the association of changes in Oxyhemoglobin concentration in somatosensory cortex with heart rate & blood pressure in response to nociceptive stimuli 2. Assess the association of changes in Oxyhemoglobin concentration in somatosensory cortex with Critical Care Pain Observation Tool in response to nociceptive stimuliTimepoint: Day 1

Countries

India

Contacts

Public ContactDr. Puneet Khanna

All India Institute of Medical Sciences, New Delhi

k.punit@yahoo.com9873106516

Outcome results

None listed

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