Comparison of effect of Dexmedetomidine and Remifentanil added to Thiopental for hemodynamic responses and seizure time in mood disorder patients who are candidate for ECT
Aim of this study is evaluation of the effect of Dexmedetomidine and Remifentanil added to Thiopental on hydrodynamic responses and seizure time in mood disorder patients are candidate for ECT .
Design
This study is clinical trial and double-blind. 90 patients with mood disorder candidates for ECT will be randomly divided into two groups of Dexmedmotidine and Remifentanil. Groups of study are parallel.
Settings and conduct
90 patients with mood disorder candidate ECT referring to Amir Kabir Hospital of Arak are included in this study. The study is double-blind. This study is clinical trial.Researcher who complete questionnaire and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with mood disorder,18-50 years old
Exclusion criteria: having renal, liver, heart and lung diseases ,contraindication for ECT, patients with head injuries, patients who do not seizure after taking electroshock, patients requiring intubation after electroshock due to respiratory impairment and long-term apnea.
Intervention groups
Patients will be randomly divided into two equal groups of 45 Dexmedetomidine and Remifentanil. In the Dexmedmotidine group, 0.5 micro gram in kilogram Dexmedetomidine will be injected intravenously and slowly before anesthesia induction. In the Remifentanil group, 100 micro gram in kilogram of Remifentanil is injected intravenously and slowly.
Comparison of effect of Dexmedetomidine and Remifentanil added to Thiopental for hemodynamic responses and seizure time in mood disorder patients who are candidate for ECT
Public title
Comparison of effect of Dexmedetomidine and Remifentanil added to Thiopental for hemodynamic responses and seizure time in mood disorder patients who are candidate for ECT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with mood disorder candidate electroshock
18-55 years old
Exclusion criteria:
having renal, liver, heart and lung diseases
patients who have been in addition to psychotic mood disorders
contraindication for ECT
patients with head injuries
patients with head injuries, patients who do not seizure after taking ECT
patients requiring intubation after ECT due to respiratory impairment and long-term apnea
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome evaluator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.298
Health conditions studied
1
Description of health condition studied
Mood disorder
ICD-10 code
F06.3
ICD-10 code description
Mood disorder due to known physiological condition
Primary outcomes
1
Description
Blood pressure
Timepoint
Before, in the recovery and after the ECT
Method of measurement
Barometer
2
Description
Heart rate
Timepoint
Before, in the recovery and after the ECT
Method of measurement
Kronometer
3
Description
Seizure duration
Timepoint
Duration ECT
Method of measurement
Kronometer
4
Description
Duration recovery
Timepoint
Duration in recovery
Method of measurement
Kronometer
5
Description
Agitation
Timepoint
Before, in the recovery and after the ECT
Method of measurement
Physical examination
6
Description
Satisfaction
Timepoint
In the recovery and after the ECT
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the Dexmedmotidine group, 0.5 micro gram in kilogram Dexmedetomidine added to Thiopental will be injected intravenously and slowly before anesthesia induction.
Category
Treatment - Drugs
2
Description
Intervention group: In the Remifentanil group, 100 micro gram in kilogram of Remifentanil added Thiopental is injected intravenously and slowly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Hamidreza Jamilian
Street address
Amirkabir hospital, Parastar Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hjamilian@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3638
Fax
+98 86 3417 3638
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hamidreza Jamilian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Jamilian@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street