We sought to assess the effect of sedation on the recurrence rate of atrioventricular nodal reentrant tachycardia (AVNRT) ablation. To this end, we selected 100 patients diagnosed with AVNRT who referred to our Arrhythmia Clinic.
Inclusion criteria: Being diagnosed with AVNRT according to physical examination and ECG and thus being candidated for EPS and ablation; having only one type of arrhythmia; giving consent to treatment with sedatives.
Exclusion criteria: Not giving consent to treatment with sedatives; having two types of arrhythmia; having already undergone ablation; having a history of receiving anti-convulsive and psychotropic drugs
We randomly divided the subjects into two groups: the sedation group, which received Midazolam, Fentanyl, and Propofol per Kg (taking necessary precautions), and the control group, which received no sedatives. We, thereafter, compared the recurrence rates of ablation between the two study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011075124N1
Registration date:2011-06-08, 1390/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-08, 1390/03/18
Registrant information
Name
Ali Eskandari
Name of organization / entity
Shaheed Rajaei Cardiovascular , Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2266 3272
Email address
sepehr@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Tehran University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sedation on the Recurrence Rate of Atrioventricular Nodal Reentrant Tachycardia Ablation
Public title
Effect of Sedation on the Recurrence Rate of Atrioventricular Nodal Reentrant Tachycardia Ablation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Being diagnosed with AVNRT according to physical examination and ECG and thus being candidated for EPS and ablation; having only one type of arrhythmia; giving consent to treatment with sedatives.
Exclusion criteria: Not giving consent to treatment with sedatives; having two types of arrhythmia; having already undergone ablation; having a history of receiving anti-convulsive and psychotropic drugs
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Sheikh Fazlollah Noori Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2010-10-24, 1389/08/02
Ethics committee reference number
896/4
Health conditions studied
1
Description of health condition studied
Atrioventricular nodal reentrant tachycardia
ICD-10 code
I45.8
ICD-10 code description
Other forms of heart disease
Primary outcomes
1
Description
Recurrence of arrhythmia
Timepoint
Three months
Method of measurement
History - physical exam - ECG
Secondary outcomes
1
Description
.
Timepoint
.
Method of measurement
.
Intervention groups
1
Description
The patients were randomly divided into two groups: The sedation group received sedatives, including Midazolam (tranquilizer and soporific) at a dose of 0.03mg/kg every half hour, Fentanyl (opiate analgesic) at a dose of 1µg/kg every half hour, and Propofol (opiate) at a loading dose of 2mg and IV dosage of 100µg/kg adjusted to maintain a Ramsay sedation scale score of 2. All the aforementioned drugs were used only intra-procedurally.
Category
Treatment - Drugs
2
Description
The control group received no drugs for sedation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaei Cardiovascular, Medical and Research Center
Full name of responsible person
Dr. Amir Farjam Fazelifar
Street address
EPS Ward, Shaheed Rajaei Cardiovascular, Medical and Research Center, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Cardiovascular Research Institute
Full name of responsible person
Dr. Majid Haghjo
Street address
Shaheed Rajaei Cardiovascular, Medical and Research Center, Adjacent to Mellat Park, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Cardiovascular Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shaheed Rajaei Cardiovascular, Medical and Research Center
Full name of responsible person
Mrs. Azam Forghaniyan
Position
Technician of anesthesia
Other areas of specialty/work
Street address
Shaheed Rajaei Cardiovascular, Medical and Research Center, Adjacent to Mellat Park, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 23921
Fax
Email
Azam.Forghanian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Rajaei Cardiovascular, Medical and Research Center
Full name of responsible person
Dr. Amir Farjam Fazelifar
Position
Cardiologist- electrophysiologist
Other areas of specialty/work
Street address
Shaheed Rajaei Cardiovascular, Medical and Research Center, Adjacent to Mellat Park, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 23921
Fax
Email
Fazelifar@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)