The aim of this study: Comparison of intravenous lidocaine and intravenous magnesium sulfate in reduction of myoclonic movements following etomidate in orthopedic surgery. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be allocated into A, B and C groups. Randomization will be performed using random block sizes of 3. The study is single-center, double blind and phase 3 trial and patients and physician will be blind about the type of injection drug. Inclusion criteria: patients who candidate for orthopedic surgery. Exclusion criteria: ASA anesthesia risk class 3 and more than; emergency surgery; history of opium, anticonvulsant and sedative drugs; patients with Parkinson; contraindication for lidocaine and magnesium sulfate. Sample size: 117 patients will participate in the study with 39 patients in each group. Study groups: Intervention group: lidocaine 2% 1 mg/kg and magnesium sulfate 5 mg/kg. Control group: Distilled water 5 cc. Primary outcome: Reduction of myoclonic movements
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062134674N1
Registration date:2017-08-13, 1396/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Akram Asadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
asadpoura951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of Shahrood
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous lidocaine and intravenous magnesium sulfate in reduction of myoclonic movements fallowing etomidate in orthopedic surgery
Public title
Effect of intravenous lidocaine and intravenous magnesium sulfate in reduction of myoclonic movements
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who candidate for orthopedic surgery
Exclusion criteria: ASA anesthesia risk class 3 and higher; emergency surgery; history of opium, anticonvulsant and sedative drugs; patients with Parkinson; contraindication for lidocaine and magnesium sulfate
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
117
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
3613773955
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IRSHMUREC.1394.114
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 the main drug for induction of anesthesia
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: magnesium sulfate 5 mg/kg single dose
Category
Treatment - Drugs
2
Description
Intervention group 2: lidocaine 2% 1 mg/kg single dose
Category
Treatment - Drugs
3
Description
Control group: Distilled water 5 cc
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr Akram Asad poor
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue, Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Shahroud University of Medical Sciences, 7 Tir square, Shahroud
City
Shahroud
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, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mobina Hakimi Nia
Position
Medical Student
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 4499
Fax
Email
mobina.hakiminia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Akram Asad poor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3613773955
Phone
+98 23 3234 2001
Fax
Email
Asadpoura951@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobina Hakimi Nia
Position
Medical student
Other areas of specialty/work
Street address
shahroud University of Medical Sciences, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3234 2001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)