Comparison of Amiodarone and Lidocaine in return of spontaneous circulation in patients with ventricular fibrillation / pulseless ventricular tachycardia in CPR
Objective: Clinical trial of Comparison Amiodarone and Lidocaine in return of spontaneous circulation in patients with ventricular fibrillation / pulseless ventricular tachycardia in CPR. Design of the study: randomization using random permuted blocks, convenience sampling, one-blinded, single-center, phase II trial. Study population: all patients with cardiopulmonary arrest having inclusion criteria. Main inclusion criteria: patients with ventricular tachycardia without a pulse and ventricular fibrillation resistant to three shocks that after the second shock have received a period of epinephrine intravenously; patients with appropriate venous access; patients who are hospitalised and underwent non-traumatic arrest. Main exclusion criteria: age under 18 years; ventricular fibrillation that not different secondary to the previous rhythm; lidocaine or amiodarone cases have already been opened. Sample size: 200. Interventions: First group: administration of amiodarone 300 mg in 30 mL of normal saline rapidly and if previous rhythm continued after 5 minutes then administration of other 150 mg of amiodarone; second group: administration of lidocaine 1.5 mg per kg per hour if previous rhythm continued after 10 minutes then administration 75 mg per kg per hour of lidocaine. Intervention time: after two cycles of CPR. Outcomes: return of spontaneous circulation by checking the blood pressure and pulse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041733480N1
Registration date:2017-05-14, 1396/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-14, 1396/02/24
Registrant information
Name
Mehdi Nedadahande
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
dr.neda@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Amiodarone and Lidocaine in return of spontaneous circulation in patients with ventricular fibrillation / pulseless ventricular tachycardia in CPR
Public title
Comparison study of amiodarone and lidocaine effect in cardiopulmonary resuscitation patients
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: patients with ventricular tachycardia without a pulse and ventricular fibrillation resistant to three shocks that after the second shock have received a period of epinephrine intravenously; patients with appropriate venous access; patients who are hospitalised and underwent non-traumatic arrest. Main exclusion criteria: age under 18 years; ventricular fibrillation that not different secondary to the previous rhythm; lidocaine or amiodarone cases have already been opened.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR.ZAUMS.REC.1395.30
Health conditions studied
1
Description of health condition studied
Cardiopulmonary resuscitation
ICD-10 code
I46, I46.0
ICD-10 code description
Cardiac arrest
Primary outcomes
1
Description
Return of spontaneous circulation
Timepoint
During resuscitation
Method of measurement
Pulse and blood pressure measurement
Secondary outcomes
empty
Intervention groups
1
Description
First group: administration of amiodarone 300 mg in 30 mL of normal saline rapidly and if previous rhythm continued after 5 minutes then administration of other 150 mg of amiodarone
Category
Treatment - Drugs
2
Description
Second group: administration of lidocaine 1.5 mg per kg per hour if previous rhythm continued after 10 minutes then administration 75 mg per kg per hour of lidocaine