NCT04203368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

December 16, 2019

Last Update Submit

December 1, 2020

Conditions

Supraventricular Tachycardia

Keywords

SVTCABGverapamiladenosine

Outcome Measures

Primary Outcomes (1)

  • efficacy of the study drug

    cardioversion to sinus rhythm

    5 days postoperative

Secondary Outcomes (2)

  • ICU stay

    2 days postoperative

  • duration of extubation

    6-12 hours postoperative

Study Arms (2)

adenosine group

ACTIVE COMPARATOR

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

verapamil group

SHAM COMPARATOR

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

Interventions

adenosineDRUG

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.

adenosine group
verapamilDRUG

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

verapamil group

Eligibility Criteria

Age65 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • RCT
  • years old
  • elective CABG

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

AdenosineVerapamil

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anaesthesiology

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

February 1, 2020

Primary Completion

July 29, 2020

Study Completion

November 22, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

EG(1)