Spinal Puncture
Conditions
Keywords
Lumbar Puncture, Pediatrics, Propofol, Remifentanil, sedation, Oncology
Brief summary
The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.
Detailed description
Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.
Interventions
DRUGPropofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
DRUGPropofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of a hemato-oncological disorder * Scheduled to undergo a lumbar puncture * Aged 3-12 years * Unpremedicated
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 |
|---|---|---|
| Duration of Apnea | This outcome was measured for the duration of the procedure (lumbar puncture). | Duration of no respiratory effort |
| Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement). | This outcome was measured for the duration of the recovery phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter. | This outcome was measured for the duration of the procedure (lumbar puncture). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus. | 17 |
| 4.0 mg/kg Propofol and 0.5 ug/kg Remifentanil Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | 2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil | 4.0 mg/kg Propofol and 0.5 ug/kg Remifentanil | Total |
|---|---|---|---|
| Age, Continuous | 6.2 years STANDARD_DEVIATION 1.6 | 7.2 years STANDARD_DEVIATION 2.4 | 6.6 years STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 4 Participants | 15 Participants | 19 Participants |
| Sex: Female, Male Male | 13 Participants | 2 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Duration of Apnea
Duration of no respiratory effort
Time frame: This outcome was measured for the duration of the procedure (lumbar puncture).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2.0 mg/kg Propofol | Duration of Apnea | 110 seconds |
| 4.0 mg/kg Propofol | Duration of Apnea | 73 seconds |
Primary
Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).
Time frame: This outcome was measured for the duration of the recovery phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2.0 mg/kg Propofol | Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement). | 10 minutes |
| 4.0 mg/kg Propofol | Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement). | 23 minutes |
Secondary
Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.
Time frame: This outcome was measured for the duration of the procedure (lumbar puncture).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2.0 mg/kg Propofol | Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter. | 0 Participants |
| 4.0 mg/kg Propofol | Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter. | 0 Participants |