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Completed

NCT Number: NCT00405522

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

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.

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Key information

Conditions

Spinal Puncture Neoplasms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg

Drug

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/kg

Drug

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.

Primary outcomes

  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 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.

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 30, 2006
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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