Comparison of low dose midazolam and etomidate for the Prevention of Myoclonic Movements following general anesthesia with etomidate Injection in Electroconvulsive Therapy.
Design
This study was conducted in parallel, double-blind, randomized, 120 people who were in the Phase 3 trial were designed.
Settings and conduct
After the etomidate injection, the intensity of myoclonus was graded clinically
according to the following scale for a period of 2 min: 0, no myoclonus; 1,short movement of a body segment e.g. a finger or a wrist, 2 mild movements of two different muscles or 3, intense clonic movements in two or more muscle groups, fast adduction of a limb.
Participants/Inclusion and exclusion criteria
Inclusion criteria:120 Patients candided ECT; ASAI and ASA II; Age aged 9 to 15 years.
exclusion criteria: severe cardiovascular disease; Kidney disease; liver disease; chronic respiratory disease; intubated; drug reaction
Intervention groups
For all intervention groups, informed consent is obtained from the parents of patients. Then an appropriate peripheral vein is taken from the patients and the blood pressure and electrocardiography and pulse oximetry devices are connected to the patients, and all patients undergoing general anesthetic induction with an autoimmune dose of 0.15 mg/kg.
Intervention group A: we prescribe normal saline or 1 cc
Intervention group B: we prescribe midazolam or 0.15 mg/kg
Intervention group C: we prescribe etomidate of 0.03 mg/kg
Main outcome variables
Myoclonus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N6
Registration date:2018-07-03, 1397/04/12
Registration timing:retrospective
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Low-Dose Midazolam and Low-Dose etomidate on Prevention of Etomidate-Induced Myoclonus in electroconvulsive therapy
Public title
Comparison of low dose midazolam and etomidate for the Prevention of myoclonic Movements following etomidate Injection.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients candidate Electroconvulsive Therapy
ASA I,ASAII
Age 6 - 15 years
Exclusion criteria:
Severe cardiovascular disease
kidney disease
Liver disease
Chronic respiratory disease
drugs Allergy
discontinue of cooperation
intubation
Age
From 9 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to three groups A, B, C, using the Random Allocation computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs are in one form and in the form of a volume in the syringe by the researcher, and the hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the evaluator do not understand the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-25, 1396/03/04
Ethics committee reference number
IR.MUI.REC.1396.3.442
Health conditions studied
1
Description of health condition studied
Myoclonic Movements
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Myoclonus
Timepoint
After induction anesthesia
Method of measurement
Observation of myoclonic movements (0,1,2,3)
2
Description
Heart rate changes
Timepoint
Before the intervention, then after the intervention, , 5, 10, 20 minutes after intervention and then After The discharge time of recovery
Method of measurement
Pulse oximetry device
3
Description
Mean arterial blood pressure
Timepoint
Before the intervention, then after the intervention, , 5, 10, 20 minutes after intervention and then After The discharge time of recovery
Method of measurement
non invasive blood pressure
4
Description
Oxygen saturation
Timepoint
Before the intervention, then after the intervention, , 5, 10, 20 minutes after intervention and then After The discharge time of recovery
Method of measurement
Pulse oximetry device
5
Description
Duration of seizure
Timepoint
After intervention
Method of measurement
In seconds using a chronometer
6
Description
Recovery Duration
Timepoint
Since entering the recovery section until discharge time
Method of measurement
Minute with using a chronometer
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
During the stay in the recovery
Method of measurement
In minutes using the chronometer
2
Description
Headache
Timepoint
During the stay in the recovery
Method of measurement
Ask the patient about this complication
3
Description
Muscle Pain
Timepoint
During the stay in the recovery
Method of measurement
Ask the patient about this complication
Intervention groups
1
Description
Intervention group:
Category
Prevention
2
Description
Intervention group:
Category
Prevention
3
Description
Control group:
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahara hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulivard, Shahid Kesari highway
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghyegh Haghjoo
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Mousavi
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Charbaghbala
City
Isfahan
Province
Isfehan
Postal code
817373673
Phone
+98 313372373
Email
smmousavi717@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroayasedeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar-Jerib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3260 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Mousavi
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Charbaghbala
City
Isfahan
Province
Isfehan
Postal code
8173763673
Phone
+98 313372373
Email
smmousavi717@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available