A Phase 1/2 interventional study of Remifentanil and Remifentanil in Hematologic Diseases and Neoplasms, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-12-02.
Sponsored by The Hospital for Sick Children · Phase 1/2, Interventional, and Treatment
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.
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.
460 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.
This study's enrollment of 64 is above the median of 50 across 274 interventional studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
Drug: Remifentanil
First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
Drug: 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.
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.
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.
Incidence of Adverse Events.
Time frame: Followed for the length of the procedure.
| Milestone | Propofol 4 mg/kg | Propofol 2mg/kg |
|---|---|---|
| Started | 32 | 32 |
| Completed | 32 | 32 |
| Not completed | 0 | 0 |
Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion
| micrograms/kg | 2.0 mg/kg Propofol | 4.0 mg/kg Propofol |
|---|---|---|
| Minimum effective dose | 0.96 ± 0.23 | 0.28 ± 0.22 |
| ED98 | 1.50 ± 1.0 | 0.52 ± 1.06 |
| Participants | 2.0 mg/kg Propofol | 4.0 mg/kg Propofol |
|---|---|---|
| Bradycardia | 0 | 0 |
| Hypotension | 0 | 0 |
Collected over Adverse events were recorded from administration of study drugs until discharge from recovery room.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol 4 mg/kg | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Propofol 2mg/kg | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Event | Propofol 4 mg/kg | Propofol 2mg/kg |
|---|---|---|
| BradycardiaGeneral disorders | 0/32 | 0/32 |
| HypotensionGeneral disorders | 0/32 | 0/32 |
| Age, Continuous(years) | Propofol 4mg/kg | Propofol 2mg/kg | Total |
|---|---|---|---|
| Mean | 5.6 ± 2.6 | 5.2 ± 2.1 | 5.3 ± 2.4 |
| Sex: Female, Male(Participants) | Propofol 4mg/kg | Propofol 2mg/kg | Total |
|---|---|---|---|
| Female | 10 | 13 | 23 |
| Male | 22 | 19 | 41 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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