The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children (DexMED)
This study is currently recruiting participants.
Verified June 2013 by University of British Columbia
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01498380
First received: December 20, 2011
Last updated: June 17, 2013
Last verified: June 2013
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Purpose
Dexmedetomidine is a sedative drug that has many benefits when given to children under anesthesia, such as improved pain relief and reduced agitation following their surgery. It is usually given as an intravenous infusion over 10 minutes, to avoid the changes in heart rate and blood pressure that are occasionally seen when it is administered more quickly. However, this is often infeasible and usually inconvenient. The investigators aim to determine the dose of dexmedetomidine that can be given rapidly (over 5 seconds) without causing significant changes in heart rate and blood pressure. This will be the only study specific intervention.
| Condition | Intervention |
|---|---|
|
Hemodynamic Instability |
Drug: Dexmedetomidine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Dose of dexmedetomidine [ Time Frame: 10 minutes for each patient ] [ Designated as safety issue: No ]Dose of dexmedetomidine that can be given as a rapid bolus that does not cause significant hemodynamic effects in healthy children
Secondary Outcome Measures:
- BIS readings [ Time Frame: 10 minutes for each patient ] [ Designated as safety issue: No ]Requirement for rescue intervention, BIS readings before and after dexmedetomidine bolus
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dexmedetomidine Rapid Bolus
All subjects will receive a rapid bolus of dexmedetomidine following induction of anesthesia with propofol and remifentanil and placement of laryngeal mask airway.
|
Drug: Dexmedetomidine
The bolus dose of dexmedetomidine given will range from 0.25-2.0 mcg/kg and will be based on the up-and-down method, such that subject 1 will receive 0.5 mcg/kg and if no significant hemodynamic changes occur (heart rate decrease < 20% or blood pressure decrease/increase < 20%) the does will be increased by 0.25 mcg/kg for the subsequent subject. If significant hemodynamic changes occur (HR decrease >/= 20% or SBP/DBP/MAP decrease or increase >/= 20%) the dose will be decreased by 0.25 mcg/kg for the subsequent subject. Each subject will be observed for 10 minutes following the dexmedetomidine bolus.
Other Name: Precedex
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- ASA I-II patients
- Elective surgery
- Planned general anesthesia with TIVA
- Planned insertion of LMA
- Ages ≥ 5 to < 10 years
Exclusion Criteria:
- Cardiac disease
- Cardiac rhythm abnormalities
- Chronic hypertension
- Predicted difficult intubation
- Contraindication to LMA use
- Weight < 5th centile or > 95th centile for age
- Pre-operative administration of anxiolytics (such as benzodiazepines or opioid analgesics)
- Hypersensitivity to dexmedetomidine or any other study medication
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498380
Contacts
| Contact: Carolyn Montgomery, Dr. | 604-875-2711 | cmontgomery@cw.bc.ca |
| Contact: Dorothy Myers | 604-875-2000 ext 5319 | dmyers2@cw.bc.ca |
Locations
| Canada, British Columbia | |
| British Columbia Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Carolyne Montgomery, Dr. 604-875-2711 cmontgomery@cw.bc.ca | |
| Contact: Dorothy Myers 604-875-2000 ext 5319 dmyers2@cw.bc.ca | |
| Principal Investigator: Carolyne Montgomery, Dr. | |
| Sub-Investigator: Joy Sanders, Dr. | |
| Sub-Investigator: Mark Ansermino, Dr. | |
Sponsors and Collaborators
University of British Columbia
More Information
Additional Information:
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01498380 History of Changes |
| Other Study ID Numbers: | H11-03137 |
| Study First Received: | December 20, 2011 |
| Last Updated: | June 17, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Dexmedetomidine Precedex TIVA Rapid bolus |
Additional relevant MeSH terms:
|
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013