The goal of the article is comparison of seizure time in electro convulsive therapy (ECT) using Cisatracurium and Succinylcholine. It is a clinical trial study in phase 3, double blind randomized (Randomization with table of randomized number), without placebo control and mono-central. The study population consists of children with psychological diseases and total sample size is 60 which is divided into two groups of 30 people entitled A and B. Three drugs, Cisatracorium 50 µg/kg, Succinylcholine 0.5 mg/kg and Sodium thiopantal 2mg/kg are grouped into two packages of A and B. Package A consists of Cisatracorium and Sodium thiopantal and package B consists of Succinylcholine and Sodium thiopantal. The patients are divided into two groups receiving package A and B respectively. After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. ECT device will be attached bi-temporally and then time of seizure and tonic and clonic phases will be measured by chronometer. Moreover oxygen saturation and patient's vital signs will be measured before, during and after receiving the drugs. Main inclusion criterion is patients under 25 who are candidates to ECT and main exclusion criteria are patients with seizure time more than 90 seconds and less than 20 seconds and persistent medical problems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081229310N1
Registration date:2016-09-21, 1395/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-21, 1395/06/31
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3224 7233
Email address
b.nazemroaya@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Succinylcholine and Cisatracurium in seizure time in electroconvulsive therapy in children with psychologic disease
Public title
Comparison of effect of Succinylcholine and Cisatracurium on seizure time in electroconvulsive therapy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients under 25 years who are candidates for electroconvulsive therapy (ECT).
Exclusion criteria: persistent medical problems, seizure more than 90 seconds and less than 20 seconds, need to intubation, severe allergy, past history of seizure and epilepsy, addiction to alchohol and drugs.
Age
To 25 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done with table of randomized numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.MUI.REC.1395.3.239
Health conditions studied
1
Description of health condition studied
Attention deficit-hyperactivity disorder(ADHD)
ICD-10 code
F90
ICD-10 code description
Disturbance of activity and attention
2
Description of health condition studied
anorexia nervosa
ICD-10 code
F50
ICD-10 code description
Anorexia nervosa
3
Description of health condition studied
mental retard
ICD-10 code
F70,F71,F7
ICD-10 code description
Mental retardation
4
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
schizophrenia
5
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
6
Description of health condition studied
bipolar disorder
ICD-10 code
F30
ICD-10 code description
manic episode
7
Description of health condition studied
psychosis
ICD-10 code
F23
ICD-10 code description
acute and transient psychotic disorders
8
Description of health condition studied
conduct disorder
ICD-10 code
F91
ICD-10 code description
conduct disorder
9
Description of health condition studied
Obsessive-compulsive disorder(OCD)
ICD-10 code
F42
ICD-10 code description
obsessive compulsive disorder
10
Description of health condition studied
anxiety disorder
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
duration of seizure
Timepoint
after intervention
Method of measurement
in seconds using a chronometer
2
Description
duration of tonic phase
Timepoint
after intervention
Method of measurement
in seconds using a chronometer
3
Description
duration of clonic phase
Timepoint
after intervention
Method of measurement
in seconds using a chronometer
4
Description
Blood Pressure
Timepoint
1, 5 and 10 seconds after the shock
Method of measurement
mmhg with Manometer
5
Description
Pulse
Timepoint
1, 5 and 10 seconds after the shock
Method of measurement
Beat per minute with Pulse Oximeter
6
Description
Beat per minute with Pulse Oximeter
Timepoint
O2 saturation
Method of measurement
Percent with Pulse Oximeter
7
Description
Recovery Duration
Timepoint
From the end of seizure to full consciousness
Method of measurement
Minute with Timer
8
Description
Back to Breathe Spontaneously
Timepoint
From the end of seizure to respiration
Method of measurement
Second with Timer
Secondary outcomes
1
Description
Cough
Timepoint
After recovery
Method of measurement
Ask the patient
2
Description
Nausea and Vomiting
Timepoint
After recovery
Method of measurement
Ask the patient
3
Description
Headache
Timepoint
After recovery
Method of measurement
Ask the patient
4
Description
Muscle Pain
Timepoint
After recovery
Method of measurement
Ask the patient
5
Description
Laryngospasm
Timepoint
After recovery
Method of measurement
Evaluation of patient such as breathing and o2 sat
Intervention groups
1
Description
Group B (the control group): After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. Pharmaceutical package B which consists of 0.5 mg/kg of Succinylcholine and 2mg/kg of Sodium thiopantal will be injected through IV line.Then ECT will be attached bi-temporally and shocks will be applied to the patient and then time of tonic and clonic phases and also time of seizure will be measured by chronometer.
Category
Treatment - Drugs
2
Description
Group A (intervention group): After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. Pharmaceutical package A which consists of 50µg/kg of Cisatracurium and 2mg/kg of Sodium thiopantal will be injected through IV line. Then ECT will be attached bi-temporally to the patient and shocks will be applied to the patient. Then time of tonic and colonic phases and also duration of seizure will be measured by chronometer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahara hospital's pediatric psychiatry ward 's electroconvulsive therapy center
Full name of responsible person
Behzad Nazemroaya ,Assistant Professor, Anesthesiology and Critical Care Research Center, Isfahan Un