Protocol summary

Summary
The aim of this clinical trial is comparison of induction of anesthesia with midazolam and Sodium Thiopental and Sodium Thiopental alone, in patients selected for Electroconvulsive therapy (ECT). Inclusion criteria: patients with major depression; age over 18 year. Exclusion criteria: air way obstruction; obesity; somnolence; kidney and hepatic failure; muscle weakness; severe asthma; all ECT contraindications; patient's discontent. This is a clinical trial on 60 subjects who are selected for this study by agreement of a psychiatric. History taking and necessary examinations are done the night before ECT. These subjects are divided into two groups of 30 ones (15 male and 15 female). At the time of entrance to ECT room, their vital signs are measured and documented. In group A, Sodium Thiopental (3 mg/Kg) is injected for induction and in group B, Sodium Thiopental (1.5 mg/Kg) and midazolam (2.5 mg) are administered. In both groups Succinylcholine (0.5 mg/kg) is used for relaxation. After induction of anesthesia, standard dose of electroshock is given by psychiatric, and starting and ending point of convulsion is measured by chronometer. The subject is referred to recovery room following returning of breathing and securing vital signs, and remained until orientation recovery. Duration of anesthesia and recovery period are measured and documented.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016013010741N2
Registration date: 2016-02-11, 1394/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-11, 1394/11/22
Registrant information
Name
Minoo Ghahraman
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5814
Email address
m_ghahraman@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of research; Kerman University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative clinical trial of induction of anesthesia with midazolam and Sodium Thiopental versus Thiopental alone in patients which are candidates for Electroconvulsive therapy
Public title
Comparison of induction of anesthesia with midazolam and Sodium Thiopental and Sodium Thiopental alone, in Electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with major depression; age over 18 year. Exclusion criteria: air way obstruction; obesity; somnolence; kidney and hepatic failure; muscle weakness; severe asthma; all ECT contraindications; patient's discontent.
Age
From 17 years old to 139 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
Ethics committee of Kerman University Medical Sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
k/93/700

Health conditions studied

1

Description of health condition studied
Recurrent depressive disorder
ICD-10 code
F33
ICD-10 code description
Recurrent depressive disorder

Primary outcomes

1

Description
seizure duration
Timepoint
after giving shock
Method of measurement
Chronometer

2

Description
Recovery duration
Timepoint
after giving shock
Method of measurement
Chronometer

3

Description
anesthesia duration
Timepoint
after giving shock
Method of measurement
Chronometer

Secondary outcomes

1

Description
vital sign
Timepoint
during the session
Method of measurement
monitoring device

Intervention groups

1

Description
In group A, Sodium Thiopental (3 mg/Kg-IV) is injected for induction of anesthesia
Category
Treatment - Drugs

2

Description
in group B, patients receive intravenous Sodium Thiopental (1.5 mg/Kg) and midazolam (2.5 mg)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
SHAHID BEHESHTI HOSPITAL
Full name of responsible person
SAHA MEHRABI
Street address
Jomhouri Blvd.
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, Kerman 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
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saha Mehrabi
Position
assistant of anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
KERMAN
Postal code
Phone
+98 34 3223 5011
Fax
Email
s.mehrabi8912@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Minoo Ghahraman
Position
anesthesiologist
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
891122013@collegian.kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
SAHA MEHRBI
Position
Assistant of ANESTHESIOLOGY
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
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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