The purpose of this study is to assess the effect of lidocaine on seizure duration and hemodynamic (BP, PR) changes in electrocunvulsive therapy. A total of 72 patients will be assigned to receive 1/5mg/kg lidocaine or normal saline immediately before induction of anesthesia. Duration of convulsion and hemodynamic changes (Pulse rate and Blood Pressure) will be recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105103912N2
Registration date:2011-06-16, 1390/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-16, 1390/03/26
Registrant information
Name
Kobra Nourian
Name of organization / entity
Sharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
noorian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of lidocaine on seizure duration and hemodynamic changes in electroconvulsive therapy
Public title
Assessment of the effect of lidocaine on seizure duration and hemodynamic changes in electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 20-40 years, psychiatric disorders with ASAI-II, candidate for ECT
Exclusion criteria: heart failure, cardiac arrhythmia, drug hypersensitivity, drug abuse
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmateieh, Shahrekord
City
Shahrekord
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
753
Health conditions studied
1
Description of health condition studied
ECT
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Duration of seizure
Timepoint
after intervention
Method of measurement
clinical observation
2
Description
Blood Pressure
Timepoint
Before and immediately 3 and 5 minutes after ECT
Method of measurement
Pulse Oximetry
3
Description
Pulse Rate
Timepoint
Before and immediately and 3 and 5 minutes after ECT
Method of measurement
Pulse Oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lidocaine, 1.5 mg/kg, IV, just before induction of anesthesia
Category
Other
2
Description
Control group: Normal saline, IV, with the same volume as the intervention group, just before induction of anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Mohammadreza Abedinzadeh
Street address
Parastar ST.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Street address
Shahrekord University of Medical Sciences, Kashani St.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Lecturer, Nursing Dept,
Other areas of specialty/work
Street address
Nursing Faculty
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
noorian@skums.ac.irM_ABEDINZADE@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mohammad Reza Abedinzadeh
Position
Assistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5552
Fax
Email
m_abedinzade@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
kobra Noorian
Position
Lecturer, Nursing Dept,
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)