Phase 4
Completed N=64
The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children
Myocardial Repolarization · Healthy
Source: ClinicalTrials.gov NCT02353169 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention — 67.8; 64.0; 64.3; 66.3 ms
◆ Published Evidence
Emerging
13citations · ~2 / year
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.
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.
Linked Publications (2)
-
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.
-
Effects of Dexmedetomidine on Myocardial Repolarization in Children Undergoing General Anesthesia: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention |
67.8; 64.0; 64.3; 66.3; 395.9; 390.2 | — |
| SECONDARY Blood Glucose Levels at 15min and 30min Post-intervention |
5.3; 5.6; 5.9; 4.9; 5.0; 5.0 | — |
| SECONDARY Blood Potassium Levels at 15min and 30min Post-intervention |
3.8; 3.7; 3.8; 3.9; 3.6; 3.6 | — |
Eligibility 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 95th centile for age
- Previously diagnosed hypokalemia
- Impaired renal or liver function
- Pre-operative anxiety requiring sedatives or opioids
- Refusal to participate
Data sourced from ClinicalTrials.gov (NCT02353169) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.