Spinal PuncturePhase 3NCT00405522
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
A Phase 3 study testing Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg and Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg in people with Spinal Puncture, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Spinal Puncture
- What is being tested?
- Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg and Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Jun 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 3-12 years
- Unpremedicated
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
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.
Read the 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.
- Conditions
- Spinal Puncture
- Being tested
- Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg, Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
- Keywords
- Lumbar Puncture, Pediatrics, Propofol, Remifentanil, sedation, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kgDrug
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.
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg | Experimental | Not described Receives: Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg |
| Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg | Experimental | Not described Receives: Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Apnea
Duration of no respiratory effort
Measured: This outcome was measured for the duration of the procedure (lumbar puncture).
Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).
Measured: This outcome was measured for the duration of the recovery phase.
Secondary outcomes (1)
Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.
Measured: This outcome was measured for the duration of the procedure (lumbar puncture).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal PunctureStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Hayes, The Hospital for Sick Children
- Investigators
- Jason Hayes, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405522
- Sponsor's protocol ID
- 1000009427
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2006
- Last updated
- 8 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
- ClinicalTrials.gov ID
- NCT00405522
- Acronym / sponsor ID
- 1000009427
- Conditions
- Spinal Puncture
- Keywords
- Lumbar Puncture, Pediatrics, Propofol, Remifentanil, sedation, Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Posted 8 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg | Experimental | Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg |
| Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg | Experimental | Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 3-12 years
- Unpremedicated
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kgPatients 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. | Drug | Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg |
| Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kgPatients 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. | Drug | Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg |
Primary outcome
Duration of Apnea
Time frame: 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).
Time frame: This outcome was measured for the duration of the recovery phase.
1 secondary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hayes, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg and Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg in people with Spinal Puncture, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Apnea (time frame: This outcome was measured for the duration of the procedure (lumbar puncture).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.