| November 28, 2006 |
| May 27, 2008 |
| November 2006 |
| June 2007 (final data collection date for primary outcome measure) |
- Intraoperative parameters (duration of apnea, episodes of bradycardia or hypotension, heart rate, blood pressure, and oxygen saturation). [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]
- Duration of postoperative recovery (time to spontaneous eye opening, verbalization, purposeful movement). [ Time Frame: Time frame determined by outcome; followed for length of the procedure. ] [ Designated as safety issue: No ]
|
- Duration of apnea
- Duration of postoperative recovery (time to spontaneous eye opening, verbalization, purposeful movement)
|
| Complete list of historical versions of study NCT00405522 on ClinicalTrials.gov Archive Site |
| 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: Followed for the length of the procedure. ] [ Designated as safety issue: Yes ] |
| episodes of bradycardia or hypotension, heart rate, blood pressure, oxygen saturation) |
| |
| Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children |
| Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations |
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. |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
| Spinal Puncture |
| Drug: Propofol + Remifentanil |
| |
| |
| |
| Completed |
| 34 |
| June 2007 |
| June 2007 (final data collection date for primary outcome measure) |
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
|
| Both |
| 3 Years to 12 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada |
| |
| NCT00405522 |
| Jason Hayes/Principal Investigator, The Hospital for Sick Children |
| 1000009427 |
| The Hospital for Sick Children |
|
| Principal Investigator: |
Jason Hayes, MD |
The Hospital for Sick Children, Toronto Canada |
|
|
| The Hospital for Sick Children |
| May 2008 |
