Effect of Alfentanil on cardiac Troponin in patients treated with Electroconvulsive therapy

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201112248504N1
• Date of registration: 2017-01-27
• Prospective Registration: No
• Primary sponsor: Arak University of Medical Sciences
• Public title: Effect of Alfentanil on cardiac Troponin in patients treated with Electroconvulsive therapy
• Scientific title: Effect of alfentanil on cardiac troponin in patients treated with Electroconvulsive therapy
• Date of first enrolment: 2015-08-23
• Target sample size: 120
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/8964
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr Mohammad Khalili
• Affiliation: Arak University of Medical Sciences

• Name: Vahid Damanpak Moghaddam
• Affiliation: Arak University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: Hospitalized patients, who have mood disorder confirmed by ?psychiatrist according to DSM-IV-TR criteria and have Electroconvulsive ?therapy indication; ASA I and II; 20 to 60 years??.?
Exclusion criteria: Patient's unwillingness to participate in study; pregnancy; ?heart failure; other conditions resulting in myocardial cell damage leading to an ?increase in Troponin I include myocarditis, cardiac surgery, angina, unstable ?angina, congestive heart failure and non-cardiac causes such as kidney failure; ?chronic diseases; musculoskeletal and pulmonary embolism; uncontrolled ?hypertension and hypertension; active gastrointestinal ulcer or bleeding, ?Inflammatory bowel disease; history of severe kidney or liver failure; ?concomitant use of corticosteroids; intracranial hemorrhage or stroke; unstable ?vascular aneurysms; neurological diseases (bulky mass or a history of seizure ?disorders); severe lung problems; ASA class IV and V; smokers with Chronic ?Obstructive Pulmonary Disease; receiving Electroconvulsive therapy in the ?last 2 months.
Exclusion criteria:

Age minimum: 20 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Mood [affective] disorders.
Mood [affective] disorders

Mood [affective] disorders

F30-F39

Intervention(s)

We inject 1 milliliter of placebo (Normal saline) and Electroconvulsive therapy ?treatment protocol in control group.

Placebo

Treatment - Drugs

Intervention 1: We inject 10microgeram in kilogram intravenous Alfentanil of 10 milliliter and ?Electroconvulsive therapy in intervention group. Intervention 2: We inject 1 milliliter of placebo (Normal saline) and Electroconvulsive therapy ?treatment protocol in control group.

We inject 10microgeram in kilogram intravenous Alfentanil of 10 milliliter and ?Electroconvulsive therapy in intervention group.

Primary Outcome(s)

Mean arterial pressure. Timepoint: Before drug administration, before and after Electroconvulsive therapy ?. Method of measurement: millimeter Hg.

Cardiac Troponin. Timepoint: Before drug administration, before and after Electroconvulsive therapy ?. Method of measurement: Micrograms per liter.

Systolic blood pressure. Timepoint: Before drug administration, before and after Electroconvulsive therapy ?. Method of measurement: millimeter Hg.

Diastolic blood pressure. Timepoint: Before drug administration, before and after ECT. Method of measurement: mmHg.

Heart Rate. Timepoint: Before drug administration, before and after Electroconvulsive therapy ?. Method of measurement: beat per minute.

Source(s) of Monetary Support

Arak University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee Arak University Of Medical Sciences