Protocol summary

Summary
The purpose of this study is comparison of the effect of pretreatment with low dose of Midazolam, low dose of Etomidate, Remifentanyl, and Magnesium sulphate on reduction or prevention of Myoclonous (Some type of jerky movement of muscle) after Etomidate induction in orthopedic surgery. Inclusion criteria: ASA ( American Society of Anesthesiologists) I, II; age between 18 to 59 years old. Exclusion criteria: patients with Neurological problems; allergy; those who have received sedative or analgesic drugs in the 24 hours ago. Patients in randomized blocks are divided into four groups: Midazolam (M) 0.015 mg/kg (M.S) 30 mg/kg, Magnesium sulphate3 Remifentanyl (R)1 micg/kg Etomidate 0.03 mg/kg (E) intravenously. All drugs are injected intravenously. In the operation room, patients are monitored for standard electrocardiography, heart rate, pulse oximetry and non-invasive blood pressure. Induction of the anesthesia is the same way in all groups by using of 0.3 mg/kg etomidate intravenously After etomidate injection for 90 seconds, the presence and severity of myoclonus is checked. Assessment of myoclonus after injection of Etomidate is performed by another anesthesiologist who is blinded to the study procedure. Myoclonus is divided to 4 grades: 0: without myoclonus; 1: movement just in wrist; 2: movement in arm, elbow and shoulder and 3: movement in whole of the body.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070613456N1
Registration date: 2014-08-14, 1393/05/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-08-14, 1393/05/23
Registrant information
Name
Abbas Sedighinejad
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 132 5712
Email address
a_sedighinejad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of pretreatment with low dose of midazolam, low dose of etomidate, remifentanyl and sulfate magnesium on reduction or prevention of myoclonus after etomidate induction in orthopedic surgery
Public title
Reduction or prevention of Myoclonus after Etomidate infusion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA ( American Society of Anesthesiologists) I, II; age between 18 to 59 years old. Exclusion criteria: patients with Neurological problems; allergy; those who have received sedative or analgesic drugs in the 24 hours ago.
Age
From 18 years old to 59 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 284
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan university of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
1930175710

Health conditions studied

1

Description of health condition studied
Myoclonus
ICD-10 code
G25.3
ICD-10 code description
Drug-induced myoclonus

Primary outcomes

1

Description
Myoclonus
Timepoint
Within 90 seconds after injection of Etomidate as the main drug for induction of anesthesia
Method of measurement
Myoclonus Grade

Secondary outcomes

empty

Intervention groups

1

Description
Intervention1: Injection of low dose of Midazolam 0.015mg/kg as a premed before Etomidate
Category
Prevention

2

Description
Intervention 2: Injection of sulfate magnesium 30 mg/kg before induction of anesthesia with Etomidate
Category
Prevention

3

Description
Intervention 3: Injection of Remifentanyl 1 micg/kg before Etomidate
Category
Prevention

4

Description
Intervention 4: Injection of low dose of Etomidate 0.03 mg/kg before induction of anesthesia with Etomidate
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Abbas sedighinejad
Street address
Parastar Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist/ Associated Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1322 3960
Fax
+98 13 1324 5132
Email
arcguilan1392@gums.ac.ir;a_sedighinejad@gums.ac.ir
Web page address
www.arc.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist/Assistant proffessor
Other areas of specialty/work
Street address
Poursina hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1322 3960
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com;A_sedighinejad@gums.ac.ir
Web page address
www.arc.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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