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

Primary Purpose

Post Operative Arrythmia

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium sulfate
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Arrythmia

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kasralainy Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

control group

dexmedetomidine group

Dexmedetomidine Mgso4 group

Arm Description

patients will receive normal saline instead of dexmedetomidine and MgSo4 .

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

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

Outcomes

Primary Outcome Measures

Incidence of postoperative JET
Incidence of postoperative JET for 72 hours postoperatively.

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2022
Last Updated
September 23, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05554848
Brief Title
Dexmedetomidine and Magnesium Sulfate in Preventing Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery
Official Title
Efficacy of Dexmedetomidine and Magnesium Sulfate in Preventing Postoperative Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Arrythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
patients will receive normal saline instead of dexmedetomidine and MgSo4 .
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Arm Description
patients will receive the same of dexmedetomidine as MD group in addition to normal saline instead of Magnesium Sulfate .
Arm Title
Dexmedetomidine Mgso4 group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postoperative JET
Description
Incidence of postoperative JET for 72 hours postoperatively.
Time Frame
for 72 hours postoperatively.
Secondary Outcome Measure Information:
Title
• Vasoactive - inotropic score
Description
Inotropic score = (dopamine × 1) + (dobutamine × 1) + (adrenaline × 100) + (noradrenaline × 100) + (milrinone × 10). Dosages of above drugs were in mcg/kg/min
Time Frame
for 72 hours postoperatively.
Title
prognostic indices
Description
• time to extubation ( in hours), ICU stay (in days) , and hospital stay (in days)
Time Frame
for 72 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kasralainy Faculty of Medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Elhaddad, MD
Phone
o1224042847
Email
drblacksmith5@kasralainy.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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