Effect of single dose intravenous dexamethasone on post-operative pain in patients undergoing laparoscopic cholecystectomy in Razi hospital during 2012
This double blind randomized clinical trial will be carried out on 122 patients who are admitted in Razi hospital and are candidates of laparoscopic cholecystectomy in order to assess the effect of single dose intravenous dexamethasone on post-operative pain in this kind of surgery. Inclusion criteria consist of patients aged between 18 to 60 years old, while the exclusion criteria are renal failure, hepatic failure, history of gastric/duodenal ulcers, sensitivity to glucocorticoid(s), and those under treatment with glucocorticoids and/or immunosuppressive agents. The sample will be divided into two groups of 61 patients. Each patient in the case group will receive 8 mg single dose intravenous dexamethasone during induction of anesthesia while patients of control group will receive normal saline as placebo at the same time. The severity of post-operative pain will be assessed in both groups in recovery, and 2, 6, 12 and 24 hours post-operatively, and will be compared to each other statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072810424N1
Registration date:2013-02-27, 1391/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-27, 1391/12/09
Registrant information
Name
Babak Masoudrad
Name of organization / entity
Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7543
Email address
masoudrad.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jondishapour University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single dose intravenous dexamethasone on post-operative pain in patients undergoing laparoscopic cholecystectomy in Razi hospital during 2012
Public title
Effect of dexamethasone on post-operative pain in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidates of laparoscopic cholecystectomy that are 18 to 60 years old.
Exclusion criteria: Patients younger than 18 or elder than 60 years old; Renal failure; Hepatic failure; History of gastric/duodenal ulcers; Sensitivity to glucocorticoid(s); Those under treatment with glucocorticoids and/or immunosuppressive agents.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
N/A
Secondary trial Id
N/A
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jondishapour University of Medical Sciences