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

NCT ID: NCT00405522

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-06-30

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.

Conditions

Spinal Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg

Group Type: EXPERIMENTAL

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg

Intervention Type: 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

Group Type: EXPERIMENTAL

Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jason Hayes

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Hayes, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000009427

Identifier Type: -

Identifier Source: org_study_id