Exploratory Propofol Dose Finding Study In Neonates

Phase 2

Completed

• Conditions: Neonatal Disorder; Adverse Reaction to Drug
• Interventions: Drug: propofol administration

• Registration Number: NCT01621373
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates).

Detailed Description

The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol (short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous bolus. This is part of routine clinical care in patients receiving (semi-) elective intubation. It's the aim to explore the most effective IV propofol dose for a successful INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen for propofol in neonates.

Intubation condition score was assessed retrospectively by the intubating physician.

Study Timeline

• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-18
• Status Verified: 2012-08
• Study Start: 2012-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2023-04-14
• Results First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Results First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Neonates admitted to the Neonatal Intensive Care Unit who need short procedural sedation for (semi-) elective intubation will be considered for inclusion, after informed written consent of the parents.
• Patients can be included if they are hemodynamically stable and did not receive sedative or analgesic agents during the previous 24 hours.

Exclusion Criteria

• Known propofol intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
propofol	propofol administration	All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.

Primary Outcome Measures

Name	Time	Method
Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure	1 hour after propofol administration	An up-and-down dose-response design was used to calculate ED50 (mg/kg) in strata with effective sampling size of at least 6, by use of the Dixon-Massey method for small samples.

Trial Locations

Locations (1)

Neonatal Intensive Care Unit UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium