Protocol summary

Summary
The purpose of this study: Comparison of changes in blood pressure and heart rate ;following the use of Sodium Thiopental or Ketamine duration and after ECT. Study design:This clinical trial was a randomized double-blind way without controls. Inclusion criteria: patients candidates receiving electroconvulsive therapy seizures; Subjects younger than 25 years old with American society of anesthesiology physical status class 1 (ASAI) . Exclusion criteria: After receiving the shock, hemodynamic unstable.; patients with seizure duration more than 90 seconds less than 20 seconds;After receiving the shock، tracheal intubation indicated; drugs used to react strongly. Sample size:68 patients were divided into two groups of 32. Studied interventions: Ketamine and thiopental was given to another group. Time of intervention: 2015-16. Outcomes studied: In 1st , 5th and 10th minute after seizure blood pressure and heart rate have been measured. After seizure patients got into recovery phase. During this time Apnea have been measured. Patients have been assessed for complications like nausea , vomiting and laryngospasm during recovery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030726950N1
Registration date: 2016-06-20, 1395/03/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of changes in blood pressure and heart rate ;following the use of Sodium Thiopental or Ketamine duration and after ECT
Public title
The effect of the two drugs( Sodium Thiopental or Ketamine) duration and after ECT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidates receiving electroconvulsive therapy seizures; Subjects younger than 25 years old with American society of anesthesiology physical status class 1 (ASAI) . Exclusion criteria: After receiving the shock, hemodynamic unstable.; patients with seizure duration more than 90 seconds less than 20 seconds;After receiving the shock، tracheal intubation indicated; drugs used to react strongly.
Age
From 6 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research of Isfahan University Of Medical Sciences
Street address
Vice Chancellor for Research, Building 4, Isfahan University Of Medical Sciences, Hezarjirib St, Isfahan
City
Isfahan
Postal code
7346181746
Approval date
2015-10-25, 1394/08/03
Ethics committee reference number
IR.MUI.REC.94.3.523

Health conditions studied

1

Description of health condition studied
Succinylcholine Chloride
ICD-10 code
T48.1
ICD-10 code description
Poisoning: Skeletal muscle relaxants [neuromuscular blocking agents], Skeletal muscle relaxants [neuromuscular blocking agents]

2

Description of health condition studied
Sodium Thiopental
ICD-10 code
T41.1
ICD-10 code description
Poisoning:Intravenous anaesthetics

3

Description of health condition studied
Ketamine
ICD-10 code
T41.2
ICD-10 code description
Poisoning: Other and unspecified general anaesthetics

Primary outcomes

1

Description
Back to Breathe Spontaneously
Timepoint
From the end of seizure to respiration
Method of measurement
Second with Timer

2

Description
Seizure Duration
Timepoint
From the start to the end of seizure
Method of measurement
Second with Timer

3

Description
Blood Pressure
Timepoint
1, 5 and 10 seconds after the shock
Method of measurement
mmhg with Manometer

4

Description
Pulse
Timepoint
1, 5 and 10 seconds after the shock
Method of measurement
Beat per minute with Pulse Oximeter

5

Description
O2 saturation
Timepoint
1, 5 and 10 seconds after the shock
Method of measurement
Percent with Pulse Oximeter

6

Description
Recovery Duration
Timepoint
From the end of seizure to full consciousness
Method of measurement
Minute with Timer

Secondary outcomes

1

Description
Headache
Timepoint
After recovery
Method of measurement
Ask the patient

2

Description
Cough
Timepoint
After recovery
Method of measurement
Ask the patient

3

Description
Nausea and Vomiting
Timepoint
After recovery
Method of measurement
Ask the patient

4

Description
Laryngospasm
Timepoint
After recovery
Method of measurement
Evaluation of patient such as breathing and o2 sat

5

Description
Muscle Pain
Timepoint
After recovery
Method of measurement
Ask the patient

Intervention groups

1

Description
First group received A packages included succinylcholine (0.5 mg/kg) and Sodium thiopental (2 mg/kg).Drugs inject IV and bolusly.
Category
Treatment - Drugs

2

Description
Second group received B packages included succinylcholine (0.5 mg/kg) and Ketamine (1mg/kg).Drugs inject IV and bolusly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children Psychiatric Ward of Medical Center Al-Zahra
Full name of responsible person
Dr. Behzad Nazemroaya
Street address
Medical Center Al-Zahra, Blvd Sofeh, Shahid Keshvari Highway, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University Of Medical Sciences
Full name of responsible person
Research Vicar
Street address
Vice Chancellor for Research, Building4, Isfahan University Of Medical Sciences, Hezarjirib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Isfahan University Of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Other areas of specialty/work
Street address
Department of Anesthesiology, AL-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31366855552532
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Other areas of specialty/work
Street address
Department of Anesthesiology, Al-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31366855552532
Fax
Email
behzad_nazem@med.mui.ac.ir
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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