Comparison of Hemodynamic Changes in Administration of Ondansetron and Metoclopramide in Preventing Post Operative Nausea and Vomiting after Strabism Surgery
This is a randomized double blind clinical trial performed on 96 patients with average age of 6-12y/o, ASA (American Society of Anesthesiologists) physical status I and II candidated for strabism surgery with general anesthesia between the years 2009 till July 2010. After obtaining approval of ethic committee of university, the study was conducted in Nikookari hospital, Tabriz University of Medical Sciences. Our exclusion criteria were as follows: The patients who received antiemetics during previous 24 hours, the patients suffering from liver, renal, gastrointestinal disorders and motion sickness. The patients were consecutively randomized into two groups, ondansetron (n=48) and group of metoclopramide (n=48). In this study ondansetron 50g/kg and metoclopramide 150g/kg administered intravenously five minutes before induction of general anesthesia after routine monitoring. By using Aldrete scoring system, the patients discharged from recovery room, of course documenting of postoperative nausea and vomiting by specific scoring systems were done with the help of one of the investigators not aware of the drug used in the operating room. After 0-2, 2-6 and 6-24 hours, patients and their family were corporated for reporting of postoperative nausea and vomiting in the surgical ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101052496N5
Registration date:2011-02-19, 1389/11/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-19, 1389/11/30
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Hemodynamic Changes in Administration of Ondansetron and Metoclopramide in Preventing Post Operative Nausea and Vomiting after Strabism Surgery
Public title
Comparison of Hemodynamic Changes in Administration of Ondansetron and Metoclopramide in Preventing Post Operative Nausea and Vomiting after Strabism Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with average age of 6-12y/o, ASA (American Society of Anesthesiologists) physical status I and II candidated for strabism surgery with general anesthesia
Exclusion criteria: The patients who received antiemetics during previous 24 hours, the patients suffering from liver, renal, gastrointestinal disorders and motion sickness
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Ethic committee of tabriz university of medical sciences
Street address
Ethic committee of university, Research Vice chancellor of Tabriz University of Medical Sciences , Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Approval date
2008-07-24, 1387/05/03
Ethics committee reference number
8733
Health conditions studied
1
Description of health condition studied
Strabism
ICD-10 code
H50.9
ICD-10 code description
Strabism, unspecified
Primary outcomes
1
Description
nausea
Timepoint
After 0, 2, 6 and 24 hours of surgury
Method of measurement
Zero for not having nausea - 1, for mild nausea- 2, for moderate nausea and 3 for sever nausea
Secondary outcomes
1
Description
vomiting
Timepoint
After 0, 2, 6 and 24 hours of surgury
Method of measurement
Zero for the patients not experiencing vomiting, 1 for the little vomiting, 2 for vomiting gastric contents and 3 for vomiting food particles.
Intervention groups
1
Description
Metoclopramide (Dopamine receptor antagonist used for the treatment of nausea and vomiting) 150g/kg administered intravenously(at one time) five minutes before induction of general anesthesia after routine monitoring.
Category
Prevention
2
Description
Ondansetron (5HT3 antagonist anti-emetic used for the treatment of nausea and vomiting) 50g/kg administered intravenously(at one time) five minutes before induction of general anesthesia after routine monitoring.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari ophthalmologic hospital
Full name of responsible person
Dr.Mohammadreza Afhami
Street address
Department of anesthesia, Tabriz University of medical Sciences, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mir Ali Eteraf Oskouei
Street address
Research Vice chancellor of Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, East Azarbaijan, IRAN
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parvar Hassanzadeh Salmasi
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Department of anesthesia, Tabriz University of medical Sciences, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Postal code
Phone
+98 41 1336 7494
Fax
Email
Parvar.88@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Afhami
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of anesthesia, Tabriz University of medical Sciences, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Postal code
Phone
+98 41 1336 7494
Fax
Email
afhami.reza@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)