Introduction: Etomidate as an intravenous anesthetic drug with minimal effects on respiratory and cardiovascular stability, but its side effects is pain on injection and Myoclonus. The aim of present study is to compare the effects of Sufentanil and Midazolam as premedication in reducing myoclonus induced by intravenously administration of Etomidate.
Study design: in this randomized double blind trial, 40 adult patients with ASAІІ-ІІІ undergoing elective surgery and general anesthesia for elective ocular surgery are entered to study.
Methods: patients undergoing fluid therapy before induction of 5 cc/kg within 10 minutes. Routine monitoring including pulse oximetry, ECG, NIBP and Capnography are done for patient.
Intervention: patients were randomly assigned into two groups. The patients are divided into two groups according to a table of random numbers. First group is received Sufentanil 0.2 µ/Kg and the second group is received Midazolam 0.3 mg/kg. These drugs as premedication drugs are received 90 seconds before induction with 0.3 mg/kg Etomidate.
Outcome and measurement: Incidence of myoclonus is done by a person who had no knowledge of the groups. Severity of myoclonus is measured by According to Myoclonus Rating Scale, between 0 and 3, including 0 (no myoclonus), 1 or mild (small movements of body parts such as fingers or wrist), 2 or moderate (gentle movements of two different muscle groups, such as face and feet, 3 or severe (severe clonic movements and muscle groups on two or more extremities or rapid induction). Then two groups are compared and significant differences in the incidence of myoclonus show the effect of these medicines.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307164780N2
Registration date:2013-07-25, 1392/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-25, 1392/05/03
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2011-09-09, 1390/06/18
Expected recruitment end date
2013-11-09, 1392/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sufentanil and Midazolam for reduction of Myoclonic movements fallowing etomidate injection in candidate patients for ocular surgery
Public title
Effect of Sufentanil and Midazolam for reduction of Myoclonic movements
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: adult patients ASAІІ-ІІІ who candidate for elective surgery. Exclusion criteria: patients with impaired adrenal function; sensitivity to drugs; mental disorders, neuromuscular disorders; seizures; and electrolyte abnormalities.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mashhad University of Medical Sciences
Street address
Research vice chancellor of Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
Postal code
Approval date
2011-07-09, 1390/04/18
Ethics committee reference number
89795
Health conditions studied
1
Description of health condition studied
Myoclonic movements
ICD-10 code
G25.3
ICD-10 code description
Drug-induced myoclonus
Primary outcomes
1
Description
Myoclonus severity
Timepoint
At the end of the study
Method of measurement
According to Myoclonus Rating Scale into mild, moderate and sever
Secondary outcomes
empty
Intervention groups
1
Description
First group is received sufentanil 0.2 µ/Kg
Category
Treatment - Drugs
2
Description
Second group is received midazolam 0.3 mg/kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor of Mashhad University of medical sciences
Full name of responsible person
Dr. Tavakol Afshar
Street address
Research vice chancellor, Ghoreishy building, University street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)