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Trial record 20 of 1168 for:    adenosine

Dexmedetomidine and Adenosine: Therapeutic Use for SVT

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ClinicalTrials.gov Identifier: NCT01495481
Recruitment Status : Completed
First Posted : December 20, 2011
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Gaurav Arora, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Supraventricular Tachycardia
Interventions Drug: Dexmedetomidine
Drug: Adenosine
Enrollment 22
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Adenosine and Dexmedetomidine
Hide Arm/Group Description 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.
Period Title: Adenosine
Started 22 [1]
Completed 22
Not Completed 0
[1]
Patients first received adenosine and then dexmedetomidine.
Period Title: Washout
Started 22
Completed 22
Not Completed 0
Period Title: Dexmedetomidine
Started 22
Completed 22
Not Completed 0
Arm/Group Title Adenosine and Dexmedetomidine
Hide Arm/Group Description Patients will receive both adenosine and dexmedetomidine for the termination of SVT.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
22
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
4
  18.2%
Male
18
  81.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Termination of SVT
Hide Description Number of participants with SVT Termination within 3 minutes of medication administration
Time Frame Within 3 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Adenosine
Hide Arm/Group Description:

Patients will receive dexmedetomidine for the termination of SVT

Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push

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

Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
16 21
2.Secondary Outcome
Title Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT
Hide Description Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination
Time Frame 1 minute
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Adenosine
Hide Arm/Group Description:

Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)

Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push

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

Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
0 16
3.Secondary Outcome
Title Number of Participants With Tachyarrhythmias After Medication Administration
Hide Description Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Adenosine
Hide Arm/Group Description:

Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)

Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push

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

Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration
Hide Description 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.
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Adenosine
Hide Arm/Group Description:

Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)

Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push

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

Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Adenosine
Hide Arm/Group Description

Patients will receive dexmedetomidine for the termination of SVT

Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push

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

All-Cause Mortality
Dexmedetomidine Adenosine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine Adenosine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine Adenosine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gaurav Arora
Organization: University of Pittsburgh
Phone: 412-692-6054
EMail: gaurav.arora@chp.edu
Layout table for additonal information
Responsible Party: Gaurav Arora, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01495481     History of Changes
Other Study ID Numbers: PRO11070129
PRE-11-010 ( Other Grant/Funding Number: Hospira, Inc )
First Submitted: December 15, 2011
First Posted: December 20, 2011
Results First Submitted: February 18, 2016
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017