Dexmedetomidine and Magnesium Sulfate in Preventing Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery

Efficacy of Dexmedetomidine and Magnesium Sulfate in Preventing Postoperative Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery: Randomized Controlled Trial

to study the prophylactic effect of magnesium sulfate , dexmedetomidine or their combination in reduction the incidence of JETS postoperative

Study Overview

• Status: Completed
• Conditions: Post Operative Arrythmia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Magnesium sulfate

Detailed Description

Following approval from research and ethics committee, preoperative preparation, and anesthesia inductuion. the baseline heart rate (HR) and blood pressure (BP) will be recorded.

The patients will be divided into three groups according to the type of drug injected.

Group MD (dexmedetomidine Mgso4 group): include (40 ) patients and will receive dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period (Precedex ; Hospira Worldwide ,Lake Forest, IL).(20) and receiving Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release. with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day.(21) Group D (dexmedetomidine group): include (40 ) patients and will receive the same of dexmedetomidine as MD group in addition to normal saline instead of Magnesium Sulfate .

Group C (control group): include (40 ) patients and will receive normal saline instead of dexmedetomidine and MgSo4 .

after the end of the procedure, inhalational anesthetics will be stopped as well the muscle relaxant. The patient will be transferred to the ICU.

In ICU , the post-operative rhythm was monitored to detect the early incidence of arrythmia

Diagnostic criteria for JET included the following:

• Tachycardia with QRS similar to sinus rhythm QRS
• A ventricular rate more than 170 beats/min
• AV dissociation with or without hemodynamic compromise
• A ventricular rate faster than the atrial rate. (8) Early onset postoperative JET was defined as the presence of JET during the first 72 h postoperatively. Continuous ECG monitoring will be used continuously in the PCCU. Standard 12-lead ECG will be registered in all patients preoperatively and at the time of PCCU admission. When JET was detected on the ECG monitor this will be also documented with a standard ECG strip Patients who developed JET and were hemodynamically unstable were managed with mild hypothermia, reduction in inotropes, magnesium, digoxin, and amiodarone.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasralainy Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: less than 5 yrs.
• Weight: more than 5 kg .
• Pathology :A-V canal ,VSD ,ASD undergoing corrective surgery with normal sinus rhythm, and stable hemodynamics.

Exclusion Criteria:

• a history of arrhythmias within the last 6 months, current use of antiarrhythmic medication such as amiodarone, digoxin.
• patients with pacemaker or atrioventricular (A-V) block.
• known allergy to dexmedetomidine or magnesium sulfate.
• patients with a history of re-do surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; patients will receive normal saline instead of dexmedetomidine and MgSo4 .
Active Comparator: dexmedetomidine group; patients will receive the same of dexmedetomidine as MD group in addition to normal saline instead of Magnesium Sulfate .	Drug: Dexmedetomidine; dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period; Other Names: Precedex
Active Comparator: Dexmedetomidine Mgso4 group; patients will receive dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period (Precedex ; Hospira Worldwide ,Lake Forest, IL).(20) and receiving Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release. with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day	Drug: Dexmedetomidine; dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period; Other Names: Precedex; Drug: Magnesium sulfate; Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release. with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative JET	Incidence of postoperative JET for 72 hours postoperatively.	for 72 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Vasoactive - inotropic score	Inotropic score = (dopamine × 1) + (dobutamine × 1) + (adrenaline × 100) + (noradrenaline × 100) + (milrinone × 10). Dosages of above drugs were in mcg/kg/min	for 72 hours postoperatively.
prognostic indices	• time to extubation ( in hours), ICU stay (in days) , and hospital stay (in days)	for 72 hours postoperatively.

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia, Supraventricular; Tachycardia; Tachycardia, Ectopic Junctional; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Reproductive Control Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Membrane Transport Modulators; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Anticonvulsants; Calcium Channel Blockers; Tocolytic Agents; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: N-62-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No