Patients who are admitted with diagnosis of cholelithiasis and are candidate for laparoscopic cholecystectomy will be evaluated. 68 patients fall into two groups according to random assignment before performing cholecystectomy. Group A will receive 8 mg of intravenous dexamethasone (2 ml), 15 min before induction of anesthesia. Group B will receive 2 ml of normal saline as placebo intravenously 15 minutes before induction of anesthesia. Before surgery and 6, 12 and 24 hours after surgery, venous blood samples from patients will be taken to measure level of serum C-reactive protein (CRP) with ELISA assay. The incidence of pain is recorded with asking from patient in3 periods of time (6th, 12th and 24th hours) after operation by two nurses of ward who are not aware of randomized groups. To assess pain intensity Visual analog scale (VAS) with a 10cm-ruler will be used and patients will indicate number of pain on the ruler. In this method zero indicates no pain and ten indicates intolerable. Outcomes including CRP, pain intensity, dosage of analgesic administration (petedin) and relationship between CRP and pain intensity will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012115364N1
Registration date:2011-03-07, 1389/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-07, 1389/12/16
Registrant information
Name
Ashkan Shirooei
Name of organization / entity
Kermanshah University of Medical Sceiences
Country
Iran (Islamic Republic of)
Phone
+98 918 339 4766
Email address
dr.a.sheroey@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Dexamethasone on the prevention of elevation of C-reactive protein and pain following laparoscopic cholecystectomy
Public title
Effects of Dexamethasone on the prevention of elevation of C-reactive protein and pain following laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with diagnosis of cholelithiasis who are candidate for laparoscopic cholecystectomy. Exclusion criteria: pregnancy, age under 18 or over 80 years, body mass index over 30, presence of underlying disease, associated infection, history of previous abdominal surgery, diagnosis of empyema of gallbladder, usage of steroids and opioids during last week, and all situations which anesthetic drugs administration is contraindicated in, the selected cases will be enrolled after writing consent.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
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
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti blvrd.
City
Kermanshah
Postal code
6718818838
Approval date
2010-07-13, 1389/04/22
Ethics committee reference number
672
Health conditions studied
1
Description of health condition studied
Cholelithiasis
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Pain intensity
Timepoint
6 hours, 12 hours and 24 hours after surgery
Method of measurement
visual analog scale (VAS)
2
Description
Serum Level of CRP
Timepoint
Before surgery and 6, 12 and 24 hours after surgery
Method of measurement
level of serum CRP with Elisa assay
Secondary outcomes
1
Description
Amount of analgesic required
Timepoint
If the patient expressed pain
Method of measurement
miligram
Intervention groups
1
Description
2cc intravenous normal saline
Category
Placebo
2
Description
8 mg (2cc) intravenous dexametasone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Khosrow Setaishy
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research & Technology Affairs
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
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 & Technology Affairs
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Khosrow Setaishy
Position
Attending and consultant in general surgery, project manager
Other areas of specialty/work
Street address
No. 60, Naft st., Golestan cross
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
k.setaishy@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Khosrow Setaishy
Position
Attending and consultant in general surgery, project manager
Other areas of specialty/work
Street address
No. 60, Naft st., Golestan cross
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
k.setaishy@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ashkan Shirooei
Position
resident of general surgery/project partners
Other areas of specialty/work
Street address
No.21, Ghazali ave., Elahieh
City
Kermanshah
Postal code
Phone
+98 83 1835 7165
Fax
Email
dr.a.sheroey@kums.ac.ir shirooei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)