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Combined Remifentanil and Propofol in electroconvulsive therapy of acute mania

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138810082935N1
Enrollment
32
Registered
2010-01-25
Start date
2010-03-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder type one. Bipolar affective disorder

Interventions

Intervention 1: Remifentanil (100 µg) plus Atropine 0.5 mg (study) for induction of anesthesia before injection of Propofol. Intervention 2: Saline plus Atropine 0.5 mg for induction of anesthesia bef
Treatment - Drugs
Remifentanil (100 µg) plus Atropine 0.5 mg (study) for induction of anesthesia before injection of Propofol

Sponsors

Kurdistan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

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. 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Duration of seizure. Timepoint: during each session of ECT. Method of measurement: mesurement of duration of seizure.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Farzin Rezaei

Kurdistan University of Medical Sciences

farrezaei@muk.ac.ir Farzin.Rezaie@uok.ac.ir frrezaie@yahoo.com+98 87 1356 1822

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026