Comparison the Effect of Remifentanil-Thiopental and Ketofol on Homodynamic Responses in Patients with Major depressive disorder candidates for Electro Convulsive Therapy
Determining the effect of Remifentanil and Thiopental (group A) and Ketofol (group B) on hemodynamic status, agitation and satisfaction of patients with major depression who are candidates for electroconvulsive therapy
Design
Double-blind clinical trial, with parallel groups, phase 3, on 80 patients, randomly divided into two groups using block random method
Settings and conduct
This study is a double-blind clinical trial. 80 patients with major depressive disorder who are candidates for electroconvulsive therapy referred to Amir Kabir Hospital in Arak are included in the study. They are divided into two groups using block random method. And since this study will be conducted in double-blind method, in addition to patients, the anesthesia resident who is the assistant of the project and the intern in charge of the project will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years; with major depression Candidate for ECT; BMI in the range of 20 to 30 .
Exclusion criteria:
history of underlying diseases; pregnancy; lactation
Intervention groups
Intervention group: In group B, the anesthesia process is induced by intravenous injection of 0.5 mg / kg ketamine with 0.5 mg / kg propofol (ketofol).
Control group: In group A, 100 micrograms of remifentanil is injected intravenously before induction of anesthesia, then the anesthesia process is induced by injection of 2-3 mg / kg thiopental.
Main outcome variables
Mean arterial pressure; heart rate; blood oxygen saturation level; Satisfaction score; agitation score; seizure duration; recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210622051672N1
Registration date:2021-07-22, 1400/04/31
Registration timing:prospective
Last update:2021-07-22, 1400/04/31
Update count:0
Registration date
2021-07-22, 1400/04/31
Registrant information
Name
Parisa Tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
parisa0075@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Remifentanil-Thiopental and Ketofol on Homodynamic Responses in Patients with Major depressive disorder candidates for Electro Convulsive Therapy
Public title
Comparison the Effect of Remifentanil-Thiopental and Ketofol in major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with major depressive disorder candidates for Electro Convulsive Therapy referred to Arak Amirkabir Hospital
All patients candidates for Electro-Convulsive Therapy who have signed an informed consent form to enter the study
Patients in the age range of 18 to 60 years
Patients with a BMI in the range of 20 to 30
Patients with major depressive disorder who do not have another psychiatric illness at the same time
Exclusion criteria:
Pregnancy
Breastfeeding
sensitivity to Remifentanil or Thiopental or Propofol
taking anticonvulsant drugs
recent CVA or MI history
history of underlying diseases of the heart, lungs, kidneys and liver
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients with inclusion criteria are randomly divided into two equal groups of remifentanil and thiopental (group A) and ketofol (group B) by the Anesthesia technician of the project. In this method, we have a total of 8 blocks that are formed based on the variables; The size of each block is 10 people and within each block, half of the patients from the intervention group and half from the control group are included.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared by an anesthesiologist in charge of the project and given to a fellow anesthesia resident who does not know the type of drugs. In both groups, the drug used for the intervention (remifentanil-thiopental and ketofol) is in the similar syringes and the volume of the injectable drug is increased to 5 cc for blinding.
Then, the information obtained from patients will be recorded in the form of a project questionnaire by the intern in charge of the project. Finally, the information obtained from the questionnaire will be analyzed by SPSS 21 software using statistical tests and will be presented in the form of statistical tables and graphs.
since this study will be conducted in double-blind method, in addition to patients, the anesthesia resident who is the assistant of the project and the intern in charge of the project will be blinded.
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 Deputy; Payambar-e-Azam Complex; Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.ARAKMU.REC.1400.057
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
Mean Arterial Pressure
Timepoint
Beginning and the end of recovery
Method of measurement
Monitor
2
Description
Pulse Rate
Timepoint
Beginning and the end of recovery
Method of measurement
Monitor
3
Description
Pulse oximetry (SpO2)
Timepoint
Beginning and the end of recovery
Method of measurement
Monitor
4
Description
Satisfaction score
Timepoint
After recovery
Method of measurement
questionnaire
5
Description
Agitation Score
Timepoint
After recovery
Method of measurement
questionnaire
6
Description
Duration of seizures
Timepoint
beginning and the end of seizures
Method of measurement
Minutes with chronometer
7
Description
duration of recovery
Timepoint
Beginning and the end of recovery
Method of measurement
Chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group B, the anesthesia process is induced by intravenous injection of 0.5 mg / kg Ketamine with 0.5 mg / kg Propofol (Ketofol) and injection of 0.5 mg / kg Succinylcholine and 0.5 mg Atropine in group B.
Category
Treatment - Drugs
2
Description
Control group: In group A, 100 micrograms of Remifentanil is injected intravenously before induction of anesthesia. For bilateral blinding of the study, the amount of drug is increased to 5 CC with normal saline. The anesthesia process is then induced by injection of 2-3 mg / kg Sodium Thiopental , 0.5 mg / kg Succinylcholine and 0.5 mg Atropine in group A.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr. Alireza Kamali
Street address
Amirkabir Hospital, Parastar Square, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Amir Almasi
Street address
Research Deputy; Payambar-e-Azam Complex; Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
amiralmasi2007@gmail.com
Web page address
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. Alireza Kamali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr Square, Shahid Shiroudi St.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
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 Square, Shahid Shiroudi St.