Protocol summary
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Study aim
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Comparison of the effect of prophylactic injection of low doses of esmolol and labetalol on changes in heart rate and blood pressure in electroshock therapy (ECT)
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. Random Allocation software is used for randomization
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Settings and conduct
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This is a double-blind clinical trial study in which the target population is ETC candidate patients at Al-Zahra Hospital in Isfahan. Patients are randomly assigned to three groups: C, B, and A, and each group is randomly injected into one of the three intervention groups. The patient's vital signs are checked and recorded before, during, and after ECT. The injector, the clinical caregiver and the patient are unaware of the injected intervention and are blind.
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Participants/Inclusion and exclusion criteria
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ECT candidate patients between the ages of 13 and 19 with class I and II ASA will be included in the study if they do not have a specific underlying problem.
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Intervention groups
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A group: 0.2 mg/kg Labetalol
B group: 0.5 mg/kg Esmolol
C group: Normal saline as pelacebo
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Main outcome variables
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Heart Rate; Blood Pressure
General information
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Reason for update
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Acronym
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ECT
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IRCT registration information
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IRCT registration number:
IRCT20160307026950N19
Registration date:
2020-06-02, 1399/03/13
Registration timing:
prospective
Last update:
2022-07-12, 1401/04/21
Update count:
1
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Registration date
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2020-06-02, 1399/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-09-22, 1399/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effectiveness of low-dose Esmolol and Labetalol on changes in heart rate and blood pressure in patients treated with electroshock (ECT)
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Public title
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Esmolol and Labetalol in ECT
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidate for electroshock therapy
Range of 13 to 19 years
ASA class I and II
The patient's consent to participate in the study
Exclusion criteria:
Contraindications to the use of Esmolol and Labetalol
Previous consumption of beta-blockers
Sensitivity to Esmolal and labetalol
Asthma and drug allergies
History of severe cardiovascular disease, chronic respiratory disease, kidney disease, and liver disease
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Age
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From 13 years old to 19 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done in a simple way and patients are distributed in intervention and control groups using Random Allocation software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The drugs and placebo are packaged in the same form with the same volume and coded and are randomly distributed among patients, so the participant and the clinical and evaluator are not aware of the type of drug.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-01, 1399/02/12
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Ethics committee reference number
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IR.MUI.MED.REC.1399.105
Health conditions studied
1
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Description of health condition studied
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Blood Pressure
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ICD-10 code
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R03.0
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ICD-10 code description
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Elevated blood-pressure reading, without diagnosis of hypertension
2
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Description of health condition studied
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Heart Rate
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ICD-10 code
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R00.0
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ICD-10 code description
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Tachycardia, unspecified
Primary outcomes
1
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Description
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Heart Rate
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Timepoint
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Before prescribing Esmolal, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
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Method of measurement
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ECG monitoring and Pulse Oximeter
2
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Description
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Systolic Blood Pressure
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Timepoint
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Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
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Method of measurement
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Non-invasive blood pressure measurement
3
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Description
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Diastolic Blood Pressure
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Timepoint
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Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
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Method of measurement
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Non-invasive blood pressure measurement
4
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Description
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Mean Arterial Pressure
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Timepoint
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Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
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Method of measurement
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Non-invasive blood pressure measurement
Secondary outcomes
1
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Description
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Oxygen saturation
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Timepoint
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Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
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Method of measurement
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Pulse oximeter
2
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Description
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The duration of the seizure
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Timepoint
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Beginning to the end of the seizure
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Method of measurement
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Chronometer
3
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Description
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The duration of anesthesia
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Timepoint
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Beginning to the end of the anesthesia
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Method of measurement
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Chronometer
4
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Description
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Recovery time
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Timepoint
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From the end of anesthesia to full awakening
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Method of measurement
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Watch
5
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Description
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Nausea and Vomiting
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Timepoint
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During the stay in the recovery
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Method of measurement
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Ask the patient about this complication
6
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Description
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Headache
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Timepoint
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During the stay in the recovery
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Method of measurement
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Asking from the patient
7
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Description
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Larangospasm
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Timepoint
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During the stay in the recovery
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Method of measurement
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Monitoring
Intervention groups
1
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Description
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Intervention Group A; Labethalol is administered at a dose of 0.2 mg per kg body weight prior to anesthesia.
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Category
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Treatment - Drugs
2
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Description
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Intervention group B; Esmolol is injected 0.5 mg per kilogram of body weight prior to anesthesia.
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Category
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Treatment - Drugs
3
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Description
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Control group C; Normal saline is injected into the patient as a placebo before injecting the anesthetic.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available