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

Spinal Puncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405522
• Other study ID #: 1000009427
• Status: Completed
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Puncture
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Apnea	Duration of no respiratory effort	This outcome was measured for the duration of the procedure (lumbar puncture).
Primary	Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).		This outcome was measured for the duration of the recovery phase.
Secondary	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).