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Comparative evaluation of midazolam effects before and after seizure occurrence on post ECT complications in teenagers

Protocol summary

Study aim
Evaluating midazolam effect before and after seizure occurrence on post ECT complications
Design
This study is a parallel randomised double-blind clinical trial designed and performed on 69 patients which is currently in phase 3.
Settings and conduct
This study is a double blinded clinical trial designed and performed in Alzahra hospital on patients with 13 to 19 years of age. Patients will be randomly divided into 3 groups and they will be receiving the drug packages. Care providers who are responsible for drug injection and care providers who are responsible for monitoring the patients are completely unaware of the content of the packages. Patients will be monitored for blood pressure, oxygen saturation, pulse rate and electrocardiogram while they are receiving ECT and 5,10 and 15 minutes after that. After the patients are completely conscious they will be evaluated based on nausea, muscle pain and headache
Participants/Inclusion and exclusion criteria
The inclusion criteria include 6 to 18 years of age, having indications for ECT, written consent from parents, npo regimen ASA I&II and the exclusion criteria include patients who do not have a stable hemodynamic status and patients who are diagnosed with major diseases like asthma, drug allergies ,neuromuscular diseases, epilepsy, hypertension and cardiovascular diseases.
Intervention groups
Patients will be randomly divided into 3 groups: group A which receives midazolam with the routine drug regimen before ECT , group B which receives midazolam after ECT and group c which is considered as the control group and receives the routine drug regimen without midazolam.
Main outcome variables
Muscle pain, headache, nausea, tachycardia, bradycardia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N16
Registration date: 2020-03-11, 1398/12/21
Registration timing: registered_while_recruiting

Last update: 2020-03-11, 1398/12/21
Update count: 0
Registration date
2020-03-11, 1398/12/21
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
2020-02-15, 1398/11/26
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of midazolam effects before and after seizure occurrence on post ECT complications in teenagers
Public title
Evaluating Midazolam effect on post ECT complications in teenagers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
13 to 18 years of age ASA I&II Having indications for ECT Written consent from parents NPO regimen
Exclusion criteria:
Patients who do not have a stable Hemodynamic status Patients with major diseases like asthma, drug allergy, neuromuscular diseases ,epilepsy, hypertension and cardiovascular diseases
Age
From 13 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 69
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly divided into three groups by using computer software and closed envelope technique. The intervention groups will receive midazolam before and after ECT and and the group receiving the routine treatments and placebo without midazolam will be considered as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be randomly divided into 3 groups by using computer software and each one of the groups will be receiving one of the 3 drug packages (package A & B & C (placebo)). drugs of three packages are prepared by the researcher using syringes of the same form and size, and the person who prescribes the drug and the person who registers the vital signs are different and are unaware of the contents of the packages finally the investigator deciphers the codes after dara analysis.
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
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.MUI.MED.REC.1398.587

Health conditions studied

1

Description of health condition studied
electroconvulsive therapy complications
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
tachycardia - bradycardia
Timepoint
0 , 5 , 10 , 15 minutes after ECT
Method of measurement
heart monitoring device

2

Description
headache
Timepoint
immediately after full consciousness , every 15 minutes in first hour then every 2 hours until 6 hours
Method of measurement
questionnaire

3

Description
myalgia
Timepoint
immediately after full consciousness , every 15 minutes in first hour then every 2 hours to 6 hour
Method of measurement
questionnaire

4

Description
nausea
Timepoint
immediately after full consciousness , every 15 minutes in first hour then every 2 hours to 6 hour
Method of measurement
questionnaire

5

Description
o2 saturation
Timepoint
before injection of drug , during seizure and 5, 10 , 15 minutes after ECT
Method of measurement
pulse oxymetery

6

Description
systolic and diastolic blood pressure
Timepoint
before drug injection, during seizures and after seizures
Method of measurement
Non invasive blood pressure monitor

7

Description
mean blood pressure
Timepoint
before drug injection, during seizures and after seizures
Method of measurement
Non invasive blood pressure monitor

8

Description
recovery time
Timepoint
From the end of seizure to full consciousness
Method of measurement
in minutes using a chornometer

9

Description
specific complications such as hypoxia and respiratory depression
Timepoint
From the end of seizure to full consciousness
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: group A which receives package A consisted of routine anesthesia medications ( sodium thiopental with a dose of 2 mg/kg and 0.5 mg/kg of succinyl choline) plus 1 mg of midazolam before inducing the seizure and administration of anesthesia drugs and 1 cc of N/S after ECT is done.
Category
Treatment - Drugs

2

Description
Intervention group: group B which receives package B consisted of the routine anesthesua medication mentioned above and 1 cc of N/S before inducing seizures and 1 mg of midazolam after the ECT is done and the seizure are completely over.
Category
Treatment - Drugs

3

Description
Control group: group C which receives 1 cc of N/S before inducing seizures and after the ECT is done as a placebo in addition to the routine anesthesia medications mentioned above.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad nazemroaya
Street address
Medical Center Al-Zahra, Blvd Sofeh, Shahid Keshvari 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
Vice Chancellor for Research of Isfahan University Of Medical Sciences
Street address
hezar jarib street
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
Maryam Raisi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amirieh town 7th ST
City
isfahan
Province
Isfehan
Postal code
8174949351
Phone
+98 913 596 7320
Email
maryamraisi1995@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
behzad nazemroaya
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Medical Center Al-Zahra, Blvd Sofeh, Shahid Keshvari Highway
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 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
Maryam Raisi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amirieh town 7th ST
City
isfahan
Province
Isfehan
Postal code
8174949351
Phone
+98 913 596 7320
Email
maryamraisi1995@yahoo.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
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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