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Trial record 5 of 1239 for:    adenosine

Adenosine Versus Verapamil for Management of Supraventricular Tachycardia Post- Coronary Artery Bypass Grafting

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ClinicalTrials.gov Identifier: NCT04203368
Recruitment Status : Not yet recruiting
First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hoda Shokri, Ain Shams University

Brief Summary:
This prospective study was conducted in 268 patients aged from 65-70 years posted for coronary artery bypass grafting. Patients were randomly allocated to either adenosine or verapamil(control) groups. In the adenosine group, patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil. In verapamil group, patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine. The efficacy of the study drug, ICU stay length, systolic blood pressure, hospital- stay length, duration of extubation, the total dose of the study drug used, the total cost of the study drugs and the incidence of adverse events were recorded.

Condition or disease Intervention/treatment Phase
Supraventricular Tachycardia Drug: adenosine Drug: verapamil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Adenosine Versus Verapamil for Management of Supraventricular Tachycardia Post- Coronary Artery Bypass Grafting: a Randomized Double Blinded Trial
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Active Comparator: adenosine group
patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil
Drug: adenosine
patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil.

Sham Comparator: verapamil group
patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine
Drug: verapamil
patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine




Primary Outcome Measures :
  1. efficacy of the study drug [ Time Frame: 5 days postoperative ]
    cardioversion to sinus rhythm


Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 2 days postoperative ]
    ICU stay duration

  2. duration of extubation [ Time Frame: 6-12 hours postoperative ]
    extubation time



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 70 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RCT
  • 65-70 years old
  • elective CABG

Exclusion Criteria:

  • impaired cerebral Perfusion
  • hemodynamic instability
  • arrhythmias other than PSVT

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Responsible Party: Hoda Shokri, Assistant professor of Anaesthesiology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04203368    
Other Study ID Numbers: FMASU R 62/ 2019
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoda Shokri, Ain Shams University:
SVT
CABG
verapamil
adenosine
Additional relevant MeSH terms:
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Adenosine
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Verapamil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents