The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children

NCT02353169 | Completed Phase 4 Results DMC

• 1 other identifier: H14-03274
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a potential change in how the heart muscles contract and changes in blood sugar and potassium levels, are poorly understood. The current study aims to examine these changes directly in healthy children undergoing elective surgery by measuring the heart beats (with an electrocardiogram) and blood sugar and potassium at specific times before and after dexmedetomidine is given. The investigators aim to establish a better understanding of this drug's safety profile.

Conditions

Myocardial Repolarization; Healthy

Keywords

changes in myocardial repolarization in healthy children

Outcome Measures

Primary Outcomes (1)

• Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention

  Absolute QTc and TP-e values 1min after a bolus of dexmedetomidine or saline. Measured with 12-lead ECG.

  60 seconds post-intervention

Secondary Outcomes (2)

• Blood Glucose Levels at 15min and 30min Post-intervention

  over 30 minutes post-intervention

• Blood Potassium Levels at 15min and 30min Post-intervention

  over 30 minutes post-intervention

Study Arms (4)

Dexmedetomidine 0.25mcg/kg

EXPERIMENTAL

0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Drug: Dexmedetomidine

Dexmedetomidine 0.5mcg/kg

EXPERIMENTAL

0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Drug: Dexmedetomidine

Dexmedetomidine 0.75mcg/kg

EXPERIMENTAL

0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Drug: Dexmedetomidine

Saline bolus

SHAM COMPARATOR

10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Drug: Saline

Interventions

Dexmedetomidine DRUG

Also known as: Precedex

Dexmedetomidine 0.25mcg/kg; Dexmedetomidine 0.5mcg/kg; Dexmedetomidine 0.75mcg/kg

Saline DRUG

Also known as: 9% NaCl

Saline bolus

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA Physical Status I-II
• Age 3 to 10yrs
• Elective surgical procedure requiring general anesthesia
• Use of dexmedetomidine acceptable to the staff anesthesiologist
• Un-premedicated
• Ability to read and understand English (parent/legal guardian(s) and child)

You may not qualify if:

• Long QT syndrome (LQTS)
• Cardiac disease or rhythm abnormalities
• Family history of LQTS or abnormal cardiac conduction
• Currently taking medications known to prolong QT
• Currently taking medications known to predispose to hypokalemia
• Known hypersensitivity to dexmedetomidine or other study medication
• Weight \< 5th centile or \> 95th centile for age
• Previously diagnosed hypokalemia
• Impaired renal or liver function
• Pre-operative anxiety requiring sedatives or opioids
• Refusal to participate

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital - Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (2)

• Gorges M, Poznikoff AK, West NC, Brodie SM, Brant RF, Whyte SD. Effects of Dexmedetomidine on Blood Glucose and Serum Potassium Levels in Children Undergoing General Anesthesia: A Secondary Analysis of Safety Endpoints During a Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1093-1099. doi: 10.1213/ANE.0000000000004154.

  PMID: 31008751 DERIVED

• Gorges M, Sherwin ED, Poznikoff AK, West NC, Brodie SM, Whyte SD. Effects of Dexmedetomidine on Myocardial Repolarization in Children Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1100-1108. doi: 10.1213/ANE.0000000000004135.

  PMID: 30985379 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Healthy children were examined in this study, thus our findings should not be extrapolated to children with long QT syndrome.

Results Point of Contact

• Title: Simon D. Whyte
• Organization: British Columbia Children's Hospital Research Institute

swhyte@cw.bc.ca

604-875-2711

Study Officials

• Simon Whyte, MBBS, FRCA

  BC Children's Hospital, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: February 2, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)