The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children

NCT01498380 | Completed DMC

• 1 other identifier: H11-03137
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability

Keywords

Dexmedetomidine; Precedex; TIVA; Rapid bolus

Outcome Measures

Primary Outcomes (1)

• Dose of dexmedetomidine

  Dose of dexmedetomidine that can be given as a rapid bolus that does not cause significant hemodynamic effects in healthy children

  10 minutes for each patient

Secondary Outcomes (1)

• BIS readings

  10 minutes for each patient

Study Arms (1)

Dexmedetomidine Rapid Bolus

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine Rapid Bolus

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-II patients
• Elective surgery
• Planned general anesthesia with TIVA
• Planned insertion of LMA
• Ages ≥ 5 to \< 10 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 5, 2017

Record last verified: 2014-02

Locations

CA (1)