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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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