Propofol and Thiopental for intravenous induction in neonates: a dose-finding study (The ProThio Study)

Phase 4

Recruiting

• Conditions: Neonates (postmenstrual age below 47 weeks) undergoing general anesthesia for any condition

• Registration Number: 2024-516072-15-00
• Lead Sponsor: Odense University Hospital

Brief Summary

To establish the effective dose 50% for the anesthetics propofol and thiopental for intravenous induction of anesthesia in newborns below the postmenstrual age of 47 weeks.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

Neonates <47 weeks postmenstrual age (PMA) undergoing general anesthesia (GA) for any condition

Exclusion Criteria

1. Allergies towards propofol or thiopental, 2. Known or family history of porphyria (thiopental only), 3. Parental refusal of insertion of an iv-line., 4. sedation within last 24 hours, 5. Contraindication to propofol or thiopental according to the attending anesthesiologist, not mentioned above.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loss of eyelash reflex and acceptance of facemask		Loss of eyelash reflex and acceptance of facemask

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark

Odense University Hospital

🇩🇰Odense C, Denmark

Kristian Nørholm Jensen

Site contact

20620531

kristian.noerholm.jensen@rsyd.dk