Comparison of the effectiveness of onsdansetran and metoclopramide combined with dexamethasone on the prevention of nausea and vomiting after laproscopic cholecystectomy
The purpose of this study is to compare the effects of ondansetrone with metoclopramide and dexamethasone on the incidence of nausea and vomiting after laparoscopic cholecystectomy. This study is a double blind trial on 100 patients, aged 16-60, with ASA I-II. The patients who have undergone elective laparoscopic cholecystectomy under general anesthesia are randomly assigned to receive an injection of 4mg ondansetrone plus 8mg dexamethasone or 10mg metoclopramide plus 8mg dexamethasone 5 minutes before the end of surgery. Incidence of nausea and vomiting are assessed and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009084715N1
Registration date:2010-10-14, 1389/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-14, 1389/07/22
Registrant information
Name
Yosof Mortazavi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4142
Email address
y.mortazavi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of onsdansetran and metoclopramide combined with dexamethasone on the prevention of nausea and vomiting after laproscopic cholecystectomy
Public title
Comparison of the effectiveness of onsdansetran and metoclopramide combined with dexamethasone on the prevention of nausea and vomiting after laproscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: undergoing elective cholecystectomy with laparoscopic method
Exclusion criteria: past history of post operative nausea and vomiting, motion sickness, obesity
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz St.
City
Babol
Postal code
Approval date
2010-09-06, 1389/06/15
Ethics committee reference number
1391/30/ژ/پ مورخ 15/6/1389
Health conditions studied
1
Description of health condition studied
laproscopic cholecystectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract
Primary outcomes
1
Description
nausea
Timepoint
four hours after the surgery
Method of measurement
Visual scale for nausea
2
Description
Vomiting
Timepoint
four hours after the surgery
Method of measurement
visual scale for Vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Ondansetrone, 4mg plus Dexemethasone, 8mg, IV injection, 5 minutes before the end of surgery
Category
Treatment - Drugs
2
Description
Metoclopramide,10mg plus Dexemethasone, 8mg, IV injection, 5 minutes before the end of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospitals
Full name of responsible person
Street address
Akberaen street, Babol
City
Babol
2
Recruitment center
Name of recruitment center
Shahid Yahyanejad hospital
Full name of responsible person
Street address
Farhang cross, Babol
City
Babol
3
Recruitment center
Name of recruitment center
Ayatolah Rohani hospital
Full name of responsible person
Street address
Keshavarz street, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
DR Mostafazade
Street address
Babol University of Medical Sciences, Ganjafroz St., Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Yosof Mortazavi
Position
Academic staff
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz St., Babol
City
Babol
Postal code
---
Phone
+98 11 1223 4142
Fax
+98 11 1223 4367
Email
mortazavi1337@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yosof Mortazavi
Position
Aacademic staff
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz St., Babol
City
Babol
Postal code
---
Phone
+98 11 1223 4142
Fax
+98 11 1223 4367
Email
mortazavi1337@yahoo.com
Web page address
---
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yosof Mortazavi
Position
---
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz St., Babol
City
Babol
Postal code
Phone
+98 11 1223 4142
Fax
Email
mortazavi1337@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)