This study was performed to evaluate the effects of Nitroglycerine on pain severity in patients undergoing Propofol injection. 100 American society of anesthesiologist class I and II patients, candidate for open leg wound surgeries were selected. Moreover, none of the participants had thin dorsal veins and any history of receiving analgesia or sedation within last 24 hours. Patients were randomly assigned to case and control groups (n=50 for each).
patients in the case group were given 200 microgram nitroglycerine ,diluted in 5 milliliter of saline intra venous from left arm. Patients in the control group received 5 milliliter of saline intra venousfrom left arm.Twenty seconds later, 100 mg of propofol were kept at room temperature was injected. propofol was administered for a period of 5 seconds. Any behavioral signs such as facial grimacing, arm withdrawal or tears and Visual analogue scale were noted by the anesthesiologist. also mean arterial blood pressure, diastolic and systolic blood pressure with a sphygmomanometer are noted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112720112N1
Registration date:2014-12-15, 1393/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the pain control effects of Nitroglycerine versus placebo during the Propofol injection
Public title
Effects of Nitroglycerine on pain during Propofol injection
Purpose
Treatment
Inclusion/Exclusion criteria
Participant inclusion criteria: American society of anesthesiologists class I and II patients; age between 18-70 years.
exclusion criteria: thin dorsal hand veins; history of receiving analgesia or sedation within last 24 hours.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Birjand University of Medical Sciences
Street address
N:56, Ghafari Ave.
City
Birjand
Postal code
1973456783421589
Approval date
2011-07-22, 1390/04/31
Ethics committee reference number
735
Health conditions studied
1
Description of health condition studied
Open wound of leg
ICD-10 code
S81.9
ICD-10 code description
Open wound of lower leg, part unspecified
Primary outcomes
1
Description
pain
Timepoint
every 30 Secondes
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
every 3 minutes
Method of measurement
sphygmomanometer
Intervention groups
1
Description
200 microgram nitroglycerine diluted in 5 milliliter of saline.
Category
Treatment - Drugs
2
Description
5 milliliter of saline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Pooya Derakhshan
Street address
Imam Reza Hostipal, Taleghani St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hasan Karbasi
Street address
Ghafari Ave.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
1974567321566549
Phone
+98 563222600
Fax
+98 563222300
Email
pooyaderkh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Talegani St.
City
Birjand
Postal code
Phone
+98 563222600
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
1974567894321132
Phone
+98 563222600
Fax
+98 563222300
Email
pooyaderakh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)