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Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405522
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Puncture Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
Study Start Date : November 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg Drug: Propofol 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.
Experimental: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg Drug: Propofol 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.


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Apnea [ Time Frame: This outcome was measured for the duration of the procedure (lumbar puncture). ]
    Duration of no respiratory effort

  2. 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. ]

Secondary Outcome Measures :
  1. 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). ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405522


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Jason Hayes, MD The Hospital for Sick Children, Toronto Canada
More Information
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Responsible Party: Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00405522    
Other Study ID Numbers: 1000009427
First Posted: November 30, 2006    Key Record Dates
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019
Last Verified: November 2018
Keywords provided by Jason Hayes, The Hospital for Sick Children:
Lumbar Puncture
Pediatrics
Propofol
 Remifentanil
sedation
Oncology
Additional relevant MeSH terms:
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Wounds and Injuries
Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents