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Comparisson of the effect of pretreatment with Hyoscine,Atropine and placebo on hemodynamic stability,recovery time,and ECT side effect

Protocol summary

Summary
Our target is comparission of hyoscine and atropine effect on patient who treat with ECT.randomized triple blind ,uni centere clinical trial.60 patients according to psychological indication and psychologist confirmation are entered and devided into 3 groups randomically excep who are older than 70 and those have medical contraindication for atropine and hyoscine. patients have tachy cardia,bradycardia,arrythmia,hypotension and hypertension are excluded.first group receive atropine0.5mg/kg as pretreatment,second group hyoscine 0.1 mg/kg and third group water0.01ml/kg .induction is done with nesdonal 2 mg/kg and succinyl choline 0.5mg/kg.blood pressure,heart rate are measured before pretreatment,after and before induction,emmediately and 1,3,5 minutes after shock.duration of convulsion according to seconds,recovery time by minutes and volume of respiratory secretions by times to suction are measured.hearte rate by ECG monitoring,duration of convulsion by EEGand o2 saturation by pulse oximetry.data collection and sampling is done from Farvardin 1393 untill Shahrivar 1393

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100719431N1
Registration date: 2015-01-12, 1393/10/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-12, 1393/10/22
Registrant information
Name
Ali Khatibi
Name of organization / entity
Iums
Country
Iran (Islamic Republic of)
Phone
+98 21 4495 4217
Email address
khatibi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical science
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisson of the effect of pretreatment with Hyoscine,Atropine and placebo on hemodynamic stability,recovery time,and ECT side effect
Public title
Effect of Hyoscine and Atropine on blood pressure ,heart rate in patient who treated by ECT
Purpose
Treatment
Inclusion/Exclusion criteria
patients according to psychological indication and psychologist confirmation are entered to study patients excep who are older than 70 and those have medical contraindication for atropine and hyoscine. patients have tachy cardia,bradycardia,arrythmia,hypotension and hypertension are excluded.
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Science
Street address
Hemmat High way
City
Tehran
Postal code
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
92د/2275/105

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

2

Description of health condition studied
Persistant delusional disorders
ICD-10 code
F22
ICD-10 code description
Persistant delusional disorder

3

Description of health condition studied
Acute and transient psychotic disorder
ICD-10 code
F23
ICD-10 code description
Acute and transient psychotic disorder

4

Description of health condition studied
Manic disorder
ICD-10 code
F30
ICD-10 code description
Manic episode

5

Description of health condition studied
Bipolar mood diorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder

6

Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
Depressive episode

7

Description of health condition studied
Paranoid personality disorder
ICD-10 code
F60.0
ICD-10 code description
Paranoid personality disorder

Primary outcomes

1

Description
heart rate
Timepoint
after and before pretreatment and after induction and immediately ,after 1,3 and 5 minutes from shock ,heart rate is measured in all patients
Method of measurement
heart rate is measuring by ECG monitoring

2

Description
duration of convulsion
Timepoint
after shock,from the firs movements of patientsto end of convulsion,time is recorded
Method of measurement
duration of convulsion is measured according to seconds

3

Description
time of recovery
Timepoint
from termination of convulsion to allertness of patient is called as recovery time.alertness means the ability of patients to obey orders
Method of measurement
time of recovery,allertness and obey is measuring according minutes

4

Description
volume of respiratory secretions
Timepoint
by convulsion termination ,respiratory secretions may ecceed normal amounts ,so we should suction them
Method of measurement
volume of secretions is measured according to how many times to sucction(1-3 times )1:dry 2:sialorrhea 3:huge amounts of secretions

5

Description
blood pressure
Timepoint
after and before pretreatment and after induction and immediately ,after 1,3 and 5 minutes from shock ,blood pressure is measured in all patients
Method of measurement
blood pressure is measured by cuff around patients arm

Secondary outcomes

1

Description
cognition disorders
Timepoint
cognition disorders are recorded during recovery time
Method of measurement
cognition disorders according to diagnosis confirmation by psychologist

2

Description
other complications
Timepoint
from the patients entrance to end of recovery
Method of measurement
every other complication occurs is recorded by inspection and visualization

3

Description
primary diagnosis
Timepoint
at first after patients entrance, primary diagnosis is recorded in data sheet
Method of measurement
at first primary diagnosis is recorded from medical records

4

Description
age
Timepoint
at first after patients entrance, age is recorded
Method of measurement
age is recorded according to medical records

5

Description
sex
Timepoint
at first,after patients entrance, sex is recorded
Method of measurement
at first sex is recorded from medical records

Intervention groups

1

Description
20 patients accidentally are belong to first group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous atropine 0.5mg (0.01 mg/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record.
Category
Treatment - Drugs

2

Description
20 patients accidentally are belong to second group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous hyoscine 5-7mg (0.1 mg/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate ,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record.
Category
Treatment - Drugs

3

Description
20 patients accidentally are belong to third group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous sterile water 1 ml (0.01 ml/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate ,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Behnaz Karimi
Street address
Anesthesiology Department of Hazrat Rasool Akram Hospital, Nyayesh street, Sattar khan, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Miss Maleki
Street address
Hemmat High way.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science
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
Iran University of Medical Science
Full name of responsible person
Behnaz Karimi
Position
Asistant
Other areas of specialty/work
Street address
Anesthesiology Department of Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4476 3217
Fax
Email
karimi.behnaz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr Ali Khatibi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department of Firoozgar Hospital, Vali asr street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
alikhatibi2002@yahoo.com khatibi
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Behnaz Karimi
Position
Assistant
Other areas of specialty/work
Street address
Anesthesiology Department of Hazrate Rasool Akram Hospital, Niayesh street, Sattar khan, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4476 3217
Fax
Email
karimi.behnaz@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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