Comparing therapeutic impacts of Magnesium sulphate and ondansetronon on propofol 2% injection pain in general anesthesia in patients undergoing vitrectomy operation
Present randomized clinical trial will perform for comparing analgesic impacts of magnesium sulfate and Ondansetron on propofol injection pain in patients undergoing viterctomy operation.in this trial, 90 patients undergone general anesthesia within vitrectomy operation between September 2012 and April 2013 will include.Subjects randomly will allocate into three groups with 30 patients: (1) magnesium sulfate group (2) Ondansetron group and (3) Normal saline group as placebo group. Pain intensity of subjects will assess by a four-point scale in four time intervals (5, 10, 20 and 25 seconds) after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092613182N3
Registration date:2013-11-10, 1392/08/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-10, 1392/08/19
Registrant information
Name
Amir Bahrami-Ahmadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 496 9707
Email address
bahramia@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2013-04-01, 1392/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing therapeutic impacts of Magnesium sulphate and ondansetronon on propofol 2% injection pain in general anesthesia in patients undergoing vitrectomy operation
Public title
Assessment of Magnesium sulphate and ondansetronon on propofol 2% injection pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:patients undergoing vitrectomy operation using general anesthesia with American Society of Anesthesiologists physical status I and II.
Exclusion: known sensitivity to propofol or ondansetron; receiving analgesic or sedative medication in the last 24 hours; presence of infection on the dorsum of the left hand; indications for rapid sequence intubation; presence of cardiac conduction defects; epilepsy; and use of antiarrhythmic medications, thin dorsal veins, renal and liver diseases, neuro-muscular diseases, pregnant women, and uncooperative patients were excluded
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethical Committee of Iran university of medical sciences
Street address
Theran-Iran
City
Research ethical committee, research deputy, Iran university of Medical Sciences, Hemat highway, Teh
Postal code
Approval date
2012-08-19, 1391/05/29
Ethics committee reference number
21781
Health conditions studied
1
Description of health condition studied
Propofol injection pain
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Propofol injection pain
Timepoint
5, 10, 20 and 25 seconds after trial intervention
Method of measurement
with 4 points scale
Secondary outcomes
empty
Intervention groups
1
Description
patients in ondansetron group: received four milligrams ondansetron
Category
Prevention
2
Description
Patients in magnesium sulfate group: received 150 mg magnesium sulfate
Category
Treatment - Drugs
3
Description
patients in placebo group: 3 milliliter normal saline 0.9%
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr Hamid Reza Faiz
Street address
Niayesh street, Satarkhan street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Faiz
Street address
Faculty of Medicine, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Amir Bahrami-Ahmadi
Position
Researcher
Other areas of specialty/work
Street address
Occupational Medicine Research center, Iran university of medical sciences, Tehran, Iran