Comparison of dexmedetomidine and alfentanil before brain shock on patient's agitation

Comparison of premedication of dexmedetomidine and alfentanil before electroconvulsive therapy on agitation and hemodynamic responses of patients with psychiatric disorders

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014103119769N1

Enrollment

Registered

2015-01-11

Start date

2014-08-23

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

Agitation. Restlessness and agitation

Interventions

Intervention 1: Intervention 1. Dexmedetomidine, 0.5 µg/kg (volume 2 ml with distilled water), IV injection. Intervention 2: Intervention 2. Alfentanil, 10 µg/kg (volume 2 ml with distilled water), IV

Treatment - Drugs

Intervention 1. Dexmedetomidine, 0.5 µg/kg (volume 2 ml with distilled water), IV injection.

Intervention 2. Alfentanil, 10 µg/kg (volume 2 ml with distilled water), IV injection.

Intervention 3. Normal saline, 2 ml, IV injection in control group.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Agitation score. Timepoint: After intervention and recovery. Method of measurement: Behavior score questionnaire.;Patient satisfaction. Timepoint: After intervention and recovery. Method of measurement: Satisfaction scale questionnaire.;Seizure duration. Timepoint: After intervention and from the onset of seizure. Method of measurement: By chronometer and recording in questionnaire.;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.;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.;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.;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.	—

Measure

Time frame

Agitation score. Timepoint: After intervention and recovery. Method of measurement: Behavior score questionnaire.;Patient satisfaction. Timepoint: After intervention and recovery. Method of measurement: Satisfaction scale questionnaire.;Seizure duration. Timepoint: After intervention and from the onset of seizure. Method of measurement: By chronometer and recording in questionnaire.;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.;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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Niknam Bagheri

Arak University of Medical Sciences

n.bagheri@arakmu.ac.ir+98 86 3417 3641

Outcome results

None listed

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