Protocol summary

Summary
This is a double blind, randomized, mono center, clinical trial with a placebo control group that will be performed in Quads hospital, Sanandaj ,Iran. Inclusion criteria include: major depression based on DSM 4 criteria, physical condition in accordance with ASA Class 1 or 2, and ability and capacity to sign informed consent sheet and exclusion criteria includes: history of major systemic disease, neuromuscular disease, and myalgia. Calculated sample size is 50 patients who will be divide randomly in two groups: Ketamine (study) and normal saline (control). Each patient will be studied at the second and third ECT sessions in a crossover method. Ketamine 30 mg or 2ml 0, 09% saline will be injected in first study ECT session and vice versa in the next ECT session in zero time. Atropine (0.5 mg) will be injected one minute later followed by induction of anesthesia with 1 mg/kg propofol at 30 second later; muscle paralysis will be achieved with 0.5 mg/kg succinylcholine. After reaching paralysis convulsion will be induced by electrical stimulation with first ECT energy doses. Seizure duration, mean arterial pressure and heart rate (at three time: pre-induction, post-induction, and post seizure) myalgia (at 6, 12, 24, and 48 hour after ECT) occurrence of headache and agitation at 24 hour after ECT will be evaluated and be recorded too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904221766N4
Registration date: 2011-11-19, 1390/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-11-19, 1390/08/28
Registrant information
Name
Karim Nasseri
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 3728
Email address
nasseri_k@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2011-10-16, 1390/07/24
Expected recruitment end date
2012-10-15, 1391/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effectiveness of ketamine on myalgia, headache and agitation in Major Depression patients after electroconvulsive therapy.
Public title
Evaluating the effectiveness of ketamine on muscle pain (myalgia), headache and restlessness (agitation) after electroconvulsive therapy in patients with major depression disorder.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Major depression based on DSM 4 criteria, physical condition in accordance with ASA Class 1 or 2, ability and capacity to sign informed consent sheet. Exclusion criteria: history of major systemic disease, history of neuromuscular disease, history of myalgia.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Pasdaran BLV , Pardis of University
City
Sanandaj
Postal code
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
14/2018

Health conditions studied

1

Description of health condition studied
Electroconvoulsive therapy induced myalgia
ICD-10 code
M79.1
ICD-10 code description
Myalgia

Primary outcomes

1

Description
Myalgia
Timepoint
At 6, 12, 24 and 48 hours after ECT
Method of measurement
Myalgia graded as follow: absence of myalgia = no; stiffness or muscle pain did not need treatment = mild; muscle pain or stiffness reported spontaneously by the patient, and required therapy = moderate; very severe discomfort = severe

2

Description
Headache
Timepoint
In the first 24 hours after ECT
Method of measurement
Visual Analoge Scale

3

Description
Agitation
Timepoint
In the recovery period
Method of measurement
1. Yes: motor restlessness, severe motor movement, and besides, un-aimed try to leave the bed, wanting to get up from bed, high loud crying, pulling catheters, confusion and poor response to verbal commands) 2 . No: not mentioned in any of the above scenarios

Secondary outcomes

1

Description
Seizure duration
Timepoint
After induction of ECT
Method of measurement
Second

2

Description
Mean arteial blood preasure
Timepoint
Befor induction of anesthesia ,after induction of anesthesia ,and after termination of seizure
Method of measurement
Milimeter of Hg

3

Description
Heart Rate
Timepoint
Befor induction of anesthesia , after induction of anesthesia ,and after termination of seizure
Method of measurement
Beat /minute

Intervention groups

1

Description
Control group: In this group 2 ml normal saline (placebo) will be injected before any other drugs in zero time.
Category
Prevention

2

Description
Study group: In this group 30 Mg Ketamine that had been diluted in 2 ml normal saline will be injected before any other drugs in zero time.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Quads Hospital
Full name of responsible person
Dr Karim Nasseri
Street address
Niroy Entezami BLV
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Ataaollah heydari
Street address
Faculty of Medicine ,Pasdaran BLV
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Faculty of Medicine
Full name of responsible person
Zohreh Ziaee
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine , Pasdaran BLV
City
Sanandaj
Postal code
Phone
+98 87 1666 4664
Fax
Email
dr.ziaee24@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Medicine
Full name of responsible person
Dr Karim Nasseri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Faculty of Medicine , Pasdaran BLV
City
Sanandaj
Postal code
Phone
+98 87 1666 0733
Fax
Email
nasseri_k@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Medicine
Full name of responsible person
Zohreh Ziaee
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine , Pasdaran BLV
City
Sanandaj
Postal code
Phone
+98 87 1666 4664
Fax
Email
dr.ziaee24@yahoo.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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