Adverse Reaction to Drug, Neonatal Disorder
Conditions
Keywords
neonatology, intratracheal intubation, propofol
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.
Interventions
Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intubation Condition Score | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propofol All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.
propofol administration: Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Propofol |
|---|---|
| Age, Categorical <=18 years | 50 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 1 day |
| Region of Enrollment Belgium | 50 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure
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.
Time frame: 1 hour after propofol administration
Population: Of the 8 strata defined by postmenstrual age and postnatal age, primary outcome of propofol ED 50 in mg/dl could be calculated in stratum 1,3 and 5.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stratum 1 | Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure | 0.792 mg/kg |
| Stratum 3 | Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure | 0.713 mg/kg |
| Stratum 5 | Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure | 1.350 mg/kg |
Other Pre-specified
Intubation Condition Score
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.
Time frame: After final intubation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum 1 | Intubation Condition Score | 7 score on a scale |
| Stratum 3 | Intubation Condition Score | 6 score on a scale |
| Stratum 5 | Intubation Condition Score | 8 score on a scale |
| Group 4 | Intubation Condition Score | 8 score on a scale |