NCT00405522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
11.8 years until next milestone

Results Posted

Study results publicly available

March 8, 2019

Completed
Last Updated

March 8, 2019

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 28, 2006

Results QC Date

April 16, 2018

Last Update Submit

November 12, 2018

Conditions

Spinal Puncture

Keywords

Lumbar PuncturePediatricsPropofolRemifentanilsedationOncology

Outcome Measures

Primary Outcomes (2)

  • Duration of Apnea

    Duration of no respiratory effort

    This outcome was measured for the duration of the procedure (lumbar puncture).

  • Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).

    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.

    This outcome was measured for the duration of the procedure (lumbar puncture).

Study Arms (2)

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

Interventions

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 2.0 mg/kg + Remifentanil 1.5 ug/kg
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.

Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of a hemato-oncological disorder
  • Scheduled to undergo a lumbar puncture
  • Aged 3-12 years
  • Unpremedicated

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

PropofolRemifentanil

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Small sample sizes

Results Point of Contact

Title
Dr. Jason Hayes
Organization
The Hospital for Sick Children, Toronto, Ontario, Canada
jason.hayes@sickkids.ca
416-813-7654

Study Officials

  • Jason Hayes, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 8, 2019

Results First Posted

March 8, 2019

Record last verified: 2018-11

Locations

CA(1)