The pain is one of the unpleasant features of the propofol intravenous injection. this study compared the effects of anesthesia with dexamethasone and fentanyl on the reduction of severity and incidence of pain during injection of propofol in surgeries.
The study was done as a randomized clinical trial: Patients of 16 to 60 years admitted for general surgery. The patients who received sedative drugs 48hr before operation, have drug allergy, with neurological disorders or mental, drug Addicts, Pregnant women and who require a rapid induction of anesthesia will exclude. From 150 patients who underwent surgery, randomly 50 subjects were placed in normal salin group, 50 in the dexamethasone group and 50 in fentanyl group. Injection of anesthetic drugs was done with Fentanyl at the dose of 100 µgr and dexamethasone at the dose of 8mg and in the normal salin at dose of 5 cc.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021015281N2
Registration date:2015-11-04, 1394/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Seyedebrahim Sadeghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 3278
Email address
esadeghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparision of effect of intervenous administration of dexametason with fentanil on reduction of propofol induced pain during intravenous injection
Public title
effect of intervenous administration of dexametason and fentanil on reduction of propofol induced pain during intravenous injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients of 16 to 60 y/o admitted for general surgery
Exclusion criteria: the patients who received sedative drugs 48hr before operation; have drug allergy; with neurological disorders or mental,drug Addicts; Pregnant women and who require a rapid induction of anesthesia
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences Front of Felestin Avenue, ,Zand Ztreet, Shiraz
City
shiraz
Postal code
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
CT-2015-249
Health conditions studied
1
Description of health condition studied
Complications of anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Effect of fentanil on reduction of propofol induced pain during intravenousinjection
Timepoint
1 minute after injection of propofol
Method of measurement
Fill questionare and visual scale
2
Description
Effect of dexametason on reduction of propofol induced pain during intravenousinjection
Timepoint
1 minute after injection of propofol
Method of measurement
Fill questionare and visual scale
Secondary outcomes
1
Description
Dermal side effects
Timepoint
From injection time untii ending of recovery time
Method of measurement
Fill questionare
Intervention groups
1
Description
Control group: first group, 5 cc normal salin 0.9 , 1 min before propofol injection
Category
Treatment - Drugs
2
Description
Interventional group: second group, 8 mg dexametason, 5 cc , 1 min before propofol injection
Category
Treatment - Drugs
3
Description
Interventional group: thirth group,100 micro gram fantanil, 5 cc , 1 min before propofol injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
marvdasht hospital
Full name of responsible person
seyed ebrahim sadeghi
Street address
City
marvdasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Branch,Shiraz University of Medical Sciences
Full name of responsible person
DR kazem samadi
Street address
International Branch of Shiraz University of Medical Sciences, Office, No. 71,Next Alley 1 .Jahad Sazandegi Avenue,Azadi Squre, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Branch,Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
DR Seyedebrahim Sadeghi
Position
AssistantProfessor
Other areas of specialty/work
Street address
Marvdasht Hospital
City
Marvdasht
Postal code
Phone
+98 71 4333 3278
Fax
Email
esadeghi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DrSeyedebrahim Sadeghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Marvdasht Hospital
City
marvdasht
Postal code
Phone
+98 71 4333 3278
Fax
Email
esadeghi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyedebrahim Sadeghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Marvdasht Hospital
City
Marvdasht
Postal code
Phone
+98 71 4333 3278
Fax
Email
esadeghi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)