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Compare the outcome of combination of Fentanyl & Midazolam infusion versus Dexmedetomidine infusion in mechanically ventilated patients in ICU

A randomized controlled trial to compare the outcome of combination of Fentanyl & Midazolam infusion versus Dexmedetomidine infusion in mechanically ventilated patients in ICU - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088183
Enrollment
200
Registered
2025-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: T808- Other complications following infusion, transfusion and therapeutic injection Health Condition 3: G978- Other intraoperative and postprocedural complications and disorders of nervous system Health Condition 4: I978- Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified

Interventions

Intervention1: Dexmedetomidine infusion: Dexmedetomidine, intravenous infusion dosage: 0.3 to 0.7mcg kg hr, Duration: 3 days Control Intervention1: Combination of fentanyl and Midazolam Infusion: fen

Sponsors

NIL
Lead Sponsor
Sri Narayani Hospital and Research Centre
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged from 20 to 65 years. Patients who require mechanical ventilatory support Patients who require sedation & analgesic therapy Post operative surgical patients

Exclusion criteria

Exclusion criteria: Patients age more than 80 years Pregnancy lactation Patients with liver dysfunctions Patients with second- and third-degree heart block

Design outcomes

Primary

MeasureTime frame
The study expected outcome will be dexmedetomidine infusion in mechanically ventilated patients, reducing incidence of adverse effects & delirium compared to other Groups.Timepoint: 3 years

Secondary

MeasureTime frame
intermittent interruption of sedative infusions helps to periodically evaluate the neurological status and level of sedation in critically ill patients. hence extubation can be planned earlier, which reduced duration of Mechanical ventilation in hours and number of days stay in intensive care units.Timepoint: 1 to 2 years

Countries

India

Contacts

Public ContactVignesh J co investigator

Sri Narayani Hospital And Research Centre

vickyvj9811@gmail.com7418952943

Outcome results

None listed

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