Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
Overview
- Phase
- Phase 3
- Intervention
- Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
- Conditions
- Spinal Puncture
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Duration of Apnea
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jason Hayes
Staff Anesthesiologist
The Hospital for Sick Children
Eligibility 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
Arms & Interventions
Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Intervention: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Intervention: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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).)