A comparative study of the effect of adding Dexmedetomidin on variation in heart rate and blood pressure after the anesthesia by Thiopental sodium in children's Electroconvulsive therapy(ECT)
The effect of adding Dexmedetomidin on variation in heart rate and blood pressue after anesthesia with Thiopental sodium in electroconvulsive therapy
Design
This study was conducted in parallel ,double-blind,randomized,60 patients who were in the phase 3 trial were designed.
Settings and conduct
Patients who are referred to pediatric psychology ward of al-Zahra hospital and are candidate of receiving electroshock therapy are randomly divided into two groups including interventional group who receives 0/2 mcg/kg Dexmedetomidin and control group who receives normal salin.Then the heart rate and blood pressure of each patient is detected. Participants,care provider, outcome assessor ,are not aware of the drugtype and the investigator deciphers the codes after data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1)Patients candidate receiving electroconvulsive therapy 2)Patients younger than 25 years old 3)Patients with American Society of Anesthesiology physical status class 1,2 (ASA1 ,ASA2) 4)Patients with satisfaction to participate in study
Exclusion criteria:1)Patients with allergies to the drugs studied
Intervention groups
Initially,personal consent is obtained from parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry,capnography,and electrocardiogram are attache.Then Dexmetedomidin 0/2 mcg/kg is injected to interventional group .In control group patients are injected from syringe filled with normal salin.
Main outcome variables
Blood pressure and heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N13
Registration date:2019-06-19, 1398/03/29
Registration timing:registered_while_recruiting
Last update:2019-06-19, 1398/03/29
Update count:0
Registration date
2019-06-19, 1398/03/29
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
2018-03-21, 1397/01/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of adding Dexmedetomidin on variation in heart rate and blood pressure after the anesthesia by Thiopental sodium in children's Electroconvulsive therapy(ECT)
Public title
THE effect of adding Dexmedetomidine on variation in heart rate and blood pressure after anesthesia with Thiopental sodium in electroconvulsive therapy (Ect)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients younger than 25 years old
Patients with American society of anesthesiology physical status class 1,2 (ASA 1,ASA2)
Patients candidate receiving electroconvulsive therapy
Patients with satisfaction to participate in study
Exclusion criteria:
Patients with allergies to the drugs studied
Age
To 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block
Randomization unit: Individual
Randomization tool: Random Allocation software
Patients are randomly assigned to intervention and control groups using the Random Allocation computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared in one form and in the same 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 and data analyser do not understand the type of medication and the investigator deciphers the codes after dara analysis.
Placebo
Not 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
2018-02-09, 1396/11/20
Ethics committee reference number
IR.Mui.REC.1396.3.791
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
2
Description of health condition studied
Heart rate
ICD-10 code
R00.0
ICD-10 code description
Tachycardia, unspecified
Primary outcomes
1
Description
Heart rate changes
Timepoint
Before the intervention,during the seizure ,1,5,10 minutes after end of seizure
Method of measurement
Heart monitoring
2
Description
Mean arterial pressure
Timepoint
Before the intervention,during seizure,1,5,10 minutes after end of seizure
Method of measurement
Non invasive blood pressure monitor
3
Description
Systolic blood pressure
Timepoint
Before the intervention , during seizure , 1,5,10 minutes after end of siezure
Method of measurement
Non invasive blood pressure monitor
4
Description
Diastolic blood pressure
Timepoint
Before the intervention , during seizure , 1,5,10 minutes after end of seizure
Method of measurement
N on invasive blood pressure monitor
5
Description
Oxygen saturation
Timepoint
Before intervention ,during seizure , 1,5,10 minutes after end of seizure
Method of measurement
Percent with pulse oximeter
6
Description
Duration of seizure
Timepoint
After intervention
Method of measurement
In second using a chornometer
7
Description
Recovery time
Timepoint
From the end of seizure to full consciousness
Method of measurement
Minute with using a chornometer
8
Description
Back up self breathing time
Timepoint
From the end of seizure until back up self breathing
Method of measurement
Seconds with using a chronometer
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
After end of the seizure
Method of measurement
Questionnaire
2
Description
Laryngospasm
Timepoint
After end of the seizure
Method of measurement
Evaluation of respiration and oxygen saturation
3
Description
Headache
Timepoint
After the end of seizure
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Initially,personal consent is obtained from the parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including :pulsoximetry ,capnography and electrocardiogram are attached.In this group Dexmedetomidin 0/2 mcg/kg is injected.
Category
Treatment - Drugs
2
Description
Control group: Initially,personal consent is obtained from the parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including :pulsoximetry ,capnography and electrocardiogram are attached. In this group patients are injected from a syringe filled with Normal salin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulevard, 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
Shaghyegh Haghjoo
Street address
Hezarjarib 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
Mahtab Nourbakhsh
Position
Medical student/Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 112, Negin-abshar Building ,Rezvan Alley , First Abshar Street
City
Isfahan
Province
Isfehan
Postal code
81656-63997
Phone
+98 31 3662 5060
Email
mahtabnourbakhsh@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
Hezarjarib Street
City
Isfaan
Province
Isfehan
Postal code
8146713543
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
Mahtab Nourbakhsh
Position
Medical student /Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 112 , Negin-abshar Building ,Rezvan Alley , First Abshar Street
City
Isfahan
Province
Isfehan
Postal code
81656-63997
Phone
+98 31 3662 5060
Email
mahtabnourbakhsh@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