Protocol summary

Summary
Objectives: Electroconvulsive therapy is an effective treatment for many psychiatric disorders, especially major depression, bipolar disorder, and schizophrenia. However, some patients may suffer from agitation, hyper-dynamic responses including transient hypertension and tachycardia and decreased satisfaction after electroconvulsive therapy. Since the hyper-dynamic responses are developed due to increased levels of epinephrine and norepinephrine in plasma, alpha-2 agonists reduce the sympatho-adrenal responses induced by pain and result in hemodynamic stability and also reduce the need for anesthetics during many surgeries. Dexmedetomidine is an α2 receptor agonist with neurological and lower cardiovascular effects. Has been reported that the drug is effective in the treatment of agitation after electroconvulsive therapy. Alfentanil is a fast-acting opiate with a short duration of action. In recent studies, the drug had beneficial effects in the treatment of tachycardia and hypertension in at-risk patients without reducing seizure duration. The aim of this study is to compare the effects of these two drugs on agitation, seizure duration, and hemodynamic parameters after electroconvulsive therapy. Design: Block randomization, double blind, with placebo, trial phase 2, including 75 patients who undergo electroconvulsive therapy. Setting and conduct: Thiopental, 3 mg/kg, IV injection to induce anesthesia. Succinylcholine, 0.5 mg/kg, IV injection for muscle relaxation. Participants including major eligibility criteria: All patients who are supposed to undergo electroconvulsive therapy. Intervention: Dexmedetomidine,0.5 µg/kg (volume 2 ml with distilled water), IV injection. Alfentanil, 10 µg/kg (volume 2 ml with distilled water), IV injection. Normal saline, 2 ml, IV injection in control group. Main outcome measures: Agitation score, Patient satisfaction, Seizure duration, Systolic blood pressure, Diastolic blood pressure, Mean Arterial blood pressure, O2 saturation, Heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014103119769N1
Registration date: 2015-01-11, 1393/10/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-11, 1393/10/21
Registrant information
Name
Niknam Bagheri
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
n.bagheri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of premedication of dexmedetomidine and alfentanil before electroconvulsive therapy on agitation and hemodynamic responses of patients with psychiatric disorders
Public title
Comparison of dexmedetomidine and alfentanil before brain shock on patient's agitation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. ASA class I–II 2. Age between 18-50 years old 3. Patients satisfaction 4. Not pregnant 5. No history of cardiovascular diseases (Arrhythmia, ischemia, and heart block) 6. Not taking beta-receptor blockers 7. Not taking opioids Exclusion criteria: 1. Lack of patients cooperation 2. Patients who have tonic-clonic seizures less than 25 seconds. 3. Patients who need more than 60% of energy for tonic-clonic seizure. 4. Severe hemodynamic instability requiring medical treatment. 5. sensitivity to the drugs used in this study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients were assigned alternately to either the dexmedetomidine or alfentanil group. Patients and researchers were not aware of the type of used medication.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
92-159-17

Health conditions studied

1

Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation

Primary outcomes

1

Description
Agitation score
Timepoint
After intervention and recovery
Method of measurement
Behavior score questionnaire

2

Description
Patient satisfaction
Timepoint
After intervention and recovery
Method of measurement
Satisfaction scale questionnaire

3

Description
Seizure duration
Timepoint
After intervention and from the onset of seizure
Method of measurement
By chronometer and recording in questionnaire

4

Description
Systolic blood pressure
Timepoint
At baseline, 5, and 15 minutes after the intervention and at the end of study
Method of measurement
By sphygmometer and recording in questionnaire

5

Description
Diastolic blood pressure
Timepoint
At baseline, 5, and 15 minutes after the intervention and at the end of study
Method of measurement
By sphygmometer and recording in questionnaire

6

Description
O2 saturation
Timepoint
At baseline, 5, and 15 minutes after the intervention and at the end of study
Method of measurement
By pulse oximeter and recording in questionnaire

7

Description
Heart rate
Timepoint
At baseline, 5, and 15 minutes after the intervention and at the end of study
Method of measurement
By monitoring and recording in questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1. Dexmedetomidine, 0.5 µg/kg (volume 2 ml with distilled water), IV injection.
Category
Treatment - Drugs

2

Description
Intervention 2. Alfentanil, 10 µg/kg (volume 2 ml with distilled water), IV injection.
Category
Treatment - Drugs

3

Description
Intervention 3. Normal saline, 2 ml, IV injection in control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
Dr Niknam Bagheri
Street address
Amir kabir hospital. Parastar square. Rah-Ahan street. Arak. Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Ali Asghar Yaghoobi
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Niknam Bagheri
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
n.bagheri@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Niknam Bagheri
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
n.bagheri@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Niknam Bagheri
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
00
Fax
Email
n.bagheri@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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