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Completed

NCT Number: NCT01621373

Exploratory Propofol Dose Finding Study In Neonates

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).

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Key information

Conditions

Adverse Reaction to Drug Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Drug-Related Side Effects and Adverse Reactions Infant, Newborn, Diseases Neonatal Disorder

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neonatal Intensive Care Unit UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol Administration

Drug

Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.

Other names: Diprivan

Primary outcomes

  1. Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure

    Time frame: 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.

Other outcomes

  1. Intubation Condition Score

    Time frame: After final intubation.

    Intubation condition score at final intubation was assessed retrospectively by the intubating physician. The score as described by Viby-Mogensen was used, with the evaluation of laryngoscopy, vocal cords, coughing, jaw relaxation and limb movements. The minimum score of the intubation condition score is 5, the maximum score of the intubation condition score is 20. A score less or equal to 10 defines a good intubation condition.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates

Acronym: NEOPROP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2012
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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