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

NCT05554848 | Completed Phase 4

• 1 other identifier: N-62-2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Arrythmia

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative JET

  Incidence of postoperative JET for 72 hours postoperatively.

  for 72 hours postoperatively.

Secondary Outcomes (2)

• • Vasoactive - inotropic score

  for 72 hours postoperatively.

• prognostic indices

  for 72 hours postoperatively.

Study Arms (3)

control group

NO INTERVENTION

patients will receive normal saline instead of dexmedetomidine and MgSo4 .

dexmedetomidine group

ACTIVE COMPARATOR

patients will receive the same of dexmedetomidine as MD group in addition to normal saline instead of Magnesium Sulfate .

Drug: Dexmedetomidine

Dexmedetomidine Mgso4 group

ACTIVE COMPARATOR

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; Drug: Magnesium sulfate

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine Mgso4 group; dexmedetomidine group

Magnesium sulfate DRUG

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.

Dexmedetomidine Mgso4 group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and Pain managment

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 15, 2023
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

EG (1)