Hematologic Diseases, Neoplasms
Conditions
Keywords
spinal puncture, remifentanil, propofol, anesthesia, dose finding, pediatrics
Brief summary
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
Detailed description
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone. The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.
Interventions
DRUGRemifentanil
The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of a hemato-oncological disorder * Scheduled to undergo a lumbar puncture * Aged 4-11 years * Male or female * Unpremedicated * Willing and able to provide informed consent (or informed consent by parents)
Exclusion criteria
* Children who are known or suspected to be difficult to ventilate by face mask * Children who are deemed medically unfit to receive either of the two study medications * Children who are obese (weight for height \> 95th percentile, * Children who do not have an indwelling intravenous line
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion | Movement measured at the time of lumbar puncture needle insertion. | Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events. | Followed for the length of the procedure. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propofol 4mg/kg Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method. | 32 |
| Propofol 2mg/kg Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method. | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Propofol 4mg/kg | Propofol 2mg/kg | Total |
|---|---|---|---|
| Age, Continuous | 5.6 years STANDARD_DEVIATION 2.6 | 5.2 years STANDARD_DEVIATION 2.1 | 5.3 years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion
Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion
Time frame: Movement measured at the time of lumbar puncture needle insertion.
Population: Minimum effective dose of remifentanil to prevent movement during lumbar puncture insertion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2.0 mg/kg Propofol | Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion | Minimum effective dose | 0.96 micrograms/kg | Standard Deviation 0.23 |
| 2.0 mg/kg Propofol | Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion | ED98 | 1.50 micrograms/kg | Standard Deviation 1 |
| 4.0 mg/kg Propofol | Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion | Minimum effective dose | 0.28 micrograms/kg | Standard Deviation 0.22 |
| 4.0 mg/kg Propofol | Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion | ED98 | 0.52 micrograms/kg | Standard Deviation 1.06 |
Secondary
Incidence of Adverse Events.
Time frame: Followed for the length of the procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.0 mg/kg Propofol | Incidence of Adverse Events. | Bradycardia | 0 Participants |
| 2.0 mg/kg Propofol | Incidence of Adverse Events. | Hypotension | 0 Participants |
| 4.0 mg/kg Propofol | Incidence of Adverse Events. | Bradycardia | 0 Participants |
| 4.0 mg/kg Propofol | Incidence of Adverse Events. | Hypotension | 0 Participants |