Evaluation the effect of anesthesia with combined Remifentanil and Propofol in electroconvoulsive therapy on efficacy, cognitive effects and seizure duration in patients with severe mania
The purpose of this study is to examine the impact of anesthesia with combined Remifentanil and Propofol on efficacy and cognitive effects in patients with severe mania. 32 participants will be recruited from consecutive inpatients, diagnosed to have a manic episode by DSM-IV criteria, who were prescribed ECT by their clinicians. Patients undergo administration of either Remifentanil (100 µg) plus Atropine 0.5 mg (study) or saline plus Atropine 0.5 mg (control) always adjusted to a 2-ml volume according to the patient’s group; Severity of mania will be assessed by the Young Mania Rating Scale (YMRS) and cognitive side effects will be assessed by Mini-Mental State Examination (MMSE). Immediate cognitive side effects will be assessed by measuring post –treatment reorientation time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810082935N1
Registration date:2010-01-25, 1388/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-01-25, 1388/11/05
Registrant information
Name
Farzin Rezaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
farrezaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-03-01, 1388/12/10
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of anesthesia with combined Remifentanil and Propofol in electroconvoulsive therapy on efficacy, cognitive effects and seizure duration in patients with severe mania
Public title
Combined Remifentanil and Propofol in electroconvulsive therapy of acute mania
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
(1) a history of ECT during the preceding 6-month period;
(2) use of nonbenzodiazepine anticonvulsants (valproate, carbamazepine, lamotrigine, or topiramate), lidocaine, theophylline, or lithium during the last week;
(3) a history of rapid-cycling or mixed bipolar illness, schizophrenia, or another psychotic disorder that was not part of the mood disorder;
(4) neurological illness or severe medical illness,
5) pregnancy,
6) stroke within the past 3 months,
7) brain surgery
8) severe head trauma,
9) drug or alcohol dependence within the past 2 years.
10)seizure duration more than 90 seconds in each episodes of ECT.
Inclusion criteria:
1) diagnosis by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) (American Psychiatric Association, 2000), of a bipolar I disorder (manic episode)
2) age between 18 to 45 years old
3) The minimal score on Young Mani Rating Scale (YMRS)≥20
4) Signed informed consent
5) IQ>70
6) ASA class 1 or 2
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Kurdistan University of Kurdistan
Street address
Pasdaran Blvd-Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Approval date
2009-08-06, 1388/05/15
Ethics committee reference number
668
Health conditions studied
1
Description of health condition studied
bipolar disorder type one
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
Severity of mania
Timepoint
baseline and one day after the third, the sixth, and the last ECT sessions
Method of measurement
Young Mania Rating Scale (YMRS)
2
Description
Cognitive status
Timepoint
Mini-Mental State Examination (MMSE)
Method of measurement
baseline and one day after the third, the sixth, and the last ECT sessions
3
Description
Orientation
Timepoint
once subjects will be removed into the recovery room and will be repeated every 15 minutes
Method of measurement
post –treatment reorientation time test
Secondary outcomes
1
Description
Duration of seizure
Timepoint
during each session of ECT
Method of measurement
mesurement of duration of seizure
Intervention groups
1
Description
Remifentanil (100 µg) plus Atropine 0.5 mg (study) for induction of anesthesia before injection of Propofol
Category
Treatment - Drugs
2
Description
Saline plus Atropine 0.5 mg for induction of anesthesia before injection of Propofol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qhods hospital- Sanandaj
Full name of responsible person
Dr Farzin Rezaei
Street address
Pasdaran Blvd- Qhods hospital - Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
Pasdaran Blvd-Kurdistan university of Medical Sciences-Deputy of research- sANANDAJ
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?