Trial Outcomes & Findings for Dexmedetomidine and Adenosine: Therapeutic Use for SVT (NCT NCT01495481)

Results Overview

Number of participants with SVT Termination within 3 minutes of medication administration

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Within 3 minutes

Results posted on

2017-03-28

Participant Flow

All 22 patients recruited received both adenosine and dexmedetomidine. Adenosine was administered first ,and then SVT was reinduced. Once SVT was reinduced, dexmedetomidine was administered. The washout period was not constant because it was dependent upon the reinduction of SVT, but it was generally less than 10 min.

Participant milestones

Participant milestones
Measure	Adenosine and Dexmedetomidine Patients will receive adenosine for termination of SVT, and then dexmedetomidine for the termination of supraventricular tachycardia (SVT) and comparison will be made for efficacy and safety.
Adenosine STARTED	22
Adenosine COMPLETED	22
Adenosine NOT COMPLETED	0
Washout STARTED	22
Washout COMPLETED	22
Washout NOT COMPLETED	0
Dexmedetomidine STARTED	22
Dexmedetomidine COMPLETED	22
Dexmedetomidine NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine and Adenosine: Therapeutic Use for SVT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenosine and Dexmedetomidine n=22 Participants Patients will receive both adenosine and dexmedetomidine for the termination of SVT.
Age, Categorical <=18 years	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 minutes

Number of participants with SVT Termination within 3 minutes of medication administration

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=22 Participants Patients will receive dexmedetomidine for the termination of SVT Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push	Adenosine n=22 Participants Patients will receive Adenosine for the termination of SVT Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Termination of SVT	16 participants	21 participants

SECONDARY outcome

Timeframe: 1 minute

Evaluation of the number of participants with sinus pause \> 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=22 Participants Patients will receive dexmedetomidine for the termination of SVT Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push	Adenosine n=22 Participants Patients will receive Adenosine for the termination of SVT Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT	0 participants	16 participants

SECONDARY outcome

Timeframe: 10 minutes

Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia \& Fibrillation)and supraventricular (Atrial Flutter \& Fibrillation) after dexmedetomidine vs. adenosine administration

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=22 Participants Patients will receive dexmedetomidine for the termination of SVT Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push	Adenosine n=22 Participants Patients will receive Adenosine for the termination of SVT Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Number of Participants With Tachyarrhythmias After Medication Administration	0 participants	0 participants

SECONDARY outcome

Timeframe: 10 minutes

Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=22 Participants Patients will receive dexmedetomidine for the termination of SVT Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push	Adenosine n=22 Participants Patients will receive Adenosine for the termination of SVT Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration	1 participants	0 participants

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adenosine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gaurav Arora

University of Pittsburgh

Phone: 412-692-6054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place