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Title: Dexmedetomidine versus fentanyl for sedation in neonates undergoing surgery : A blinded randomized controlled trial

Title: Dexmedetomidine versus fentanyl for sedation in Postoperative neonates: A blinded randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039656
Enrollment
76
Registered
2022-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine infusion will be started at a maintenance infusion rate of 0.3 mcg/kg/hr. Infusion rate will be increased by 0.1 mcg/kg/hr to a maximum of 1 mcg/kg/hr.

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates > 35 weeks gestation undergoing surgery.

Exclusion criteria

Exclusion criteria: Neonates with Bradycardia (HR Neonates with hypotension and requirement of more than 2 inotropes.

Design outcomes

Primary

MeasureTime frame
Percentage of neonates with N-PASS score 3 at any point of time during study.Timepoint: 2 hourly—

Secondary

MeasureTime frame
Requirement of midazolam or fentanyl boluses Timepoint: Till end of study—

Countries

India

Contacts

Public ContactShivani Dogra

PGIMER CHANDIGARH

shivanidogra2003@yahoo.com9654217383

Outcome results

None listed

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