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A study comparing Propofol plus fentanyl and Dexmedetomidine for conscious sedation in sclerotherapy patients.

A prospective randomized controlled trial using Propofol plus fentanyl and Dexmedetomidine for conscious sedation in sclerotherapy patients.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016885
Enrollment
70
Registered
2019-01-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: D233- Other benign neoplasm of skin of other and unspecified parts of face

Interventions

Intervention1: Propofol plus fentanyl: Patient will be given fentanyl as 0.5 μg/kg/hr and propofol starting as 0.1-0.15 mg/kg/min IV for 3-5 min and then 0.025-0.075 mg/kg/min IV as sedation maintena
subsequently decrease infusion rates over time to 25 to 50 mcg/kg/min titrated every 5 minutes in steps to achieve a RSS of 4. Control Intervention1: Group 1(Propofol) Versus Group 2 (Dexmedetomidine)

Sponsors

PGIMER CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -ASA 1 -Age group of 2-12 years -Scheduled to undergo Sclerotherapy in IR department

Exclusion criteria

Exclusion criteria: -Acute Respiratory tract infections -Predicted difficult airway -History of allergy to propofol, fentanyl or dexmedetomidine -Patients on sedatives within two weeks prior to surgery

Design outcomes

Primary

MeasureTime frame
Efficacy of sedation based on intraoperative patient movement scoreTimepoint: Base Line, Before administering bolus, after bolus, Every 2.5 minutes till procedure is over.

Secondary

MeasureTime frame
Effect on hemodynamics and respiratory depression Ã? Recovery time from sedation Ã? Postoperative Pain Score (Visual Analogue Score)Timepoint: Every 2.5 minutes for hemodynmics and resiration end of procedure for pain

Countries

India

Contacts

Public ContactDr Rajeev Chauhan

PGIMER Chandigarh

dr.rajeevchauhan@gmail.com01722756500

Outcome results

None listed

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