Post Operative Nausea Vomiting is a common complication after surgery that it is unpleasant and leads to delay in discharge and other complications. The incidence of Post Operative Nausea Vomiting after strabismus surgery is high so we must to prevent it. Medical and non- medical appro aches use for this reason that Ondansetron, metoclopramide, dexamethasone are there drugs used for this. We dedicated to compare three drugs for the prevention after this surgery (for the differences between adverse effects and the selection of the best efficient drug) for this reasons in a double blind randomized clinical trial, 111 patients from 2 to 15 years old that scheduled for strabismus surgery were selected (after explaining the process of the trial, written informed consent obtained from participants).
Then they were divided into three groups randomly, for the first group Ondansetron 0.1 mg/kg, second metoclopramide 0.15 mg/kg, third dexamethasone 0.15 mg/kg were adminstered and the incidence of Post Operative Nausea Vomiting and trearment of it notated in the first hour, 1 to 6, 6 to 12, 12 to 24 hours after surgery and then were analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012051138N4
Registration date:2011-01-05, 1389/10/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-05, 1389/10/15
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2007-11-04, 1386/08/13
Expected recruitment end date
2009-06-01, 1388/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ondansetron, Metoclopramide and Dexamethasone on Post Operative Nausea Vomiting after strabismus surgery
Public title
Effect of Ondansetron, Metoclopramide and Dexamethasone on Post Operative Nausea Vomiting after strabismus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- The patients candidates for strabismus surgery between 2-15 years
2- physical class status(ASA) I-II
Exclusion criteria:
1-Historyof GI problems
2-History of known drug sensitivity to drugs used in study.
Age
From 2 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
111
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
Guilan University of Medical Sciences
Street address
siadati st.
City
Rasht
Postal code
Approval date
2007-12-22, 1386/10/01
Ethics committee reference number
442
Health conditions studied
1
Description of health condition studied
strabismus
ICD-10 code
H49-H50
ICD-10 code description
H50
Primary outcomes
1
Description
frequency of nausea and vomiting
Timepoint
In the first hour (recovery period) 1to 6 , 6 to 12 , 12to24 hours post – operation
Method of measurement
Questionnair
Secondary outcomes
1
Description
frequency of nausea and vomiting treatment
Timepoint
In the first hour (recovery period) 1to 6 , 6 to 12 , 12to24 hours post – operation
Method of measurement
questionnaire
Intervention groups
1
Description
Group A (ondansetron) 0.1mg/kg IV 30 minutes before ending surgery
Category
Treatment - Drugs
2
Description
Group B ( metoclopramide) 0.15mg/kg IV 30 minutes before ending surgery
Category
Treatment - Drugs
3
Description
Group C ( dexamethasone) 0.15mg/kg IV at the start of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Sudabeh Haddadi
Street address
Amiralmomenin Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences,Vice Chancellor for Research
Full name of responsible person
Susan Komaii
Street address
Siadati st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences,Vice Chancellor for Research
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
So_haddadi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
So_haddadi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)