Comparison of the incidence and severity of cognitive impairment after electroconvulsive therapy under general anesthesia in the two groups with remifentanil- thiopental sodium thiopental - placebo in patients referred to ECT Center shafa of Rasht in 2013
This prospective, randomized study aimed to compare the incidence and severity of cognitive impairment after electroconvulsive therapy under general anesthesia in the two groups with remifentanil - thiopental sodium or placebo- sodium thiopental. This study is double blind. 120 patients, aged 18-60 years old with psychiatric disorders diagnosed by psychiatrists according to DSMIV-TR criteria and candidates for ECT enroll in the study. Exclusion criteria are emergency ECT; severe cognitive dysfunction prior to ECT; history of mental retardation; severe heart disease; history of previous ECT; ASA physical status III-IV; uncontrolled hypertension and needs to treat agitation after ECT. The patients randomly assigned into groups of 60 to receive remifentanil 50 mic plus thiopental sodium (study group)or normal salin plus thiopental sodium (control group) in both the volume of 5 ml. Severity of cognitive impairment will assess by psychiatrists before ECT, 5 hours and 24 hours after electroconvulsive therapy with the test mini mental status exam (MMSE ).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306086280N2
Registration date:2013-06-12, 1392/03/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the incidence and severity of cognitive impairment after electroconvulsive therapy under general anesthesia in the two groups with remifentanil- thiopental sodium thiopental - placebo in patients referred to ECT Center shafa of Rasht in 2013
Public title
The effect of remifentanil - thiopental sodium on cognitive impairment after electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with psychiatric disorders diagnosed by psychiatrists according to DSMIV-TR criteria; age between 18-60 years old; signing informed consent; ASA physical status I or II; ECT candidates for the first time.
Exclusion criteria: emergency ECT; severe cognitive dysfunction prior to ECT; history of mental retardation; severe heart disease; history of previous ECT; ASA physical status III-IV; uncontrolled hypertension and needs to treat agitation after ECT.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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
Guilan University of Medical Sciences, Research and Technology
Street address
shahid beheshti Highway - End of the Skyway - up Iran Radiator
City
rasht
Postal code
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
2920029709
Health conditions studied
1
Description of health condition studied
Patient with psychiatric disorder
ICD-10 code
F10-39
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use,Schizophrenia, schizotypal and delusional disorders,Mood [affective] disorders
Primary outcomes
1
Description
incidence of cognitive impairment after electroconvulsive therapy in general anesthesia with remifentani plus thiopental sudium
Timepoint
Before ECT, 5 hours and 24 hours after ECT
Method of measurement
By testing mini mental status exam (MMSE)
2
Description
severity of cognitive impairment after electroconvulsive therapy in general anesthesia with remifentani plus thiopental sudium
Timepoint
Before ECT, 5 hours and 24 hours after ECT
Method of measurement
By testing mini mental status exam (MMSE)
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before induction of anesthesia, immediately after ECT, after entering the recovery
Method of measurement
By electronic sphygmomanometer in the ECT room
2
Description
Heart rate
Timepoint
Before induction of anesthesia, immediately after ECT, after entering the recovery
Method of measurement
By monitoring heart rate
Intervention groups
1
Description
Intervention group: remifentanil 50 mic plus thiopental sodium