Combined Remifentanil and Propofol in electroconvulsive therapy of acute mania

Phase 1

• Conditions: bipolar disorder type one.; Bipolar affective disorder

• Registration Number: IRCT138810082935N1
• Lead Sponsor: Kurdistan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion 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.

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;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.;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 Outcome Measures

Name	Time	Method
Duration of seizure. Timepoint: during each session of ECT. Method of measurement: mesurement of duration of seizure.