The Effect of single dose of dexamethasone on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy in Amir Al Momenin hospital, Semnan
Aims: The purpose of this study was to study the effect of a single dose of dexamethasone in prevention from nausea and vomiting after laparoscopic cholecystectomy. Design of the study: In a clinical trial, 90 patients undergoing laparoscopic cholecystectomy were blind to the study drug or placebo divided into two groups according to the group allocation was done. The main inclusion and exclusion criteria: Inclusion criteria: elective cholecystectomy surgery Exclusion criteria: history of nausea and vomiting in previous surgery, diabetes mellitus, hypertension, obesity, use of anti-nausea drugs within 24 hours before surgery. Sample size: 90 patients who underwent laparoscopic cholecystectomy. Interventions: Ten minutes before extubationin operating room, 5 mg dexamethasone by intravenous injection administrated for case group and 5 cc normal saline for controls. Incidence and severity of nausea or vomiting and also need to anti-emetic drugs in patients up to 24 hours after surgery was assessed and recorded by a person who did not know any matter about the patient grouping. Time of intervention: Ten minutes before extubation in the operating room. Study outcomes: Decreasing of severity and frequency of vomiting and nausea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062118168N1
Registration date:2014-07-10, 1393/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-10, 1393/04/19
Registrant information
Name
Hamid Reza Hemmati
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7822
Email address
dr.hahemmati@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Vice chancellor, Semnan University of Medical Sciences
Expected recruitment start date
2013-09-06, 1392/06/15
Expected recruitment end date
2014-03-05, 1392/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of single dose of dexamethasone on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy in Amir Al Momenin hospital, Semnan
Public title
The Effect of dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for laparoscopic cholecystectomy
Exclusion criteria: History of vomiting and nausea in previous surgery; diabetes melitus; hypertension; Obesity; use of anti emetic and nausea drugs during last 24 hours.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
1
Health conditions studied
1
Description of health condition studied
Vomiting after surgery
ICD-10 code
50.5
ICD-10 code description
استفراغ ناشی از سایر علل
Primary outcomes
1
Description
Vomiting severity
Timepoint
Up to 24 hours after surgery
Method of measurement
Based on score
Secondary outcomes
empty
Intervention groups
1
Description
Case group received dexamethasone 5 mg intravenously 10 minutes before extubation.
Category
Treatment - Drugs
2
Description
Control group received normal saline in similar volume to dexamethasone for case group 10 minutes before extubation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Dr. Hamid Reza Hemmati
Street address
Imam Hussein Square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Aasgari
Street address
Basidj Boulevard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Hemmati
Position
Assisstant professor/ Torax Surgeon
Other areas of specialty/work
Street address
Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 3343 7822
Fax
Email
dr.hahemmati@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Hemmati
Position
Assisstant professor/ Torax Surgeon
Other areas of specialty/work
Street address
Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 3343 7822
Fax
Email
dr.hahemmati@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medcial Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
Kowsar Hospital, Basidj Boulevard
City
Semnan
Postal code
Phone
00
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)