Comparing the preventive effect of variuos combinations of ondansetron,dexamethason and metoclopramide on post operative nausea and vomiting after balanced anesthesia for orthopedic surgery
The aim of this study is comparing the effectiveness of Dexamethason,Metclopramide and Ondansetron alone and in various 1-1 combinations.
420 patients age 16-65 ,American Society of Anesthesiologists Physical Status 1-2 ,with no important known organ disease who are candidate for orthopedic surgery under general anesthesia would be included.Patients would allocated into 6 intervention and 1 control groups randomly as following:
intervention group 1:ondansetron 4mg=4cc =Intravenous
intervention group 2:metoclopramid 4mg=4cc=Intravenous
intervention group 3:dexamethason 4mg=4cc =Intravenous
intervention group 4:ondansetron 4mg+metoclopramid 4mg=4cc=Intravenous
intervention group 5: ondansetron 4mg+dexamethason 4mg=4c=Intravenousc
intervention group 6: metoclopramid 4mg+dexamethason4mg=4cc=Intravenous
Goup 7=Control group :placebo =normal saline =4cc =Intravenous
Study drugs (single or 1-1 combinations) or placebo (4 cc normal saline) will be administered when the surgeon begin suturing the fascia .
Occurrence of nausea and vomiting will be measured by Post Operative Nausea and Vomiting (PONV) score at the end of recovery stay and 2 hours after transferring the patient to the ward and every 8 hours thereafter for the next 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108067093N2
Registration date:2012-09-26, 1391/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-26, 1391/07/05
Registrant information
Name
Mohsen Saber Moghadamranjbar
Name of organization / entity
North khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 4229 7069
Email address
sabermoghadam41@gmail.com
Recruitment status
Recruitment complete
Funding source
North khorasan University Of Medical Science- Deputy Of Research And Technology
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the preventive effect of variuos combinations of ondansetron,dexamethason and metoclopramide on post operative nausea and vomiting after balanced anesthesia for orthopedic surgery
Public title
comparison of various combinations of ondansetron ,dexamethson and methoclopramide for prevention of post operative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:ASA class 1,2; age 16-65;BMI<30; Candidate for orthopedic surgery
Exclusion criteria:Severe sleep apnea syndrome;Significant cardiac,respiratory,hepatic,gastrointestinal or renal disease;Known hypersensitivity to each of study drug;History of post operative nausea and vomiting in previous surgeries;Taking medication with known antivomiting properties; Pregnant or breast feeding mother; Opioid and alcohol addiction;Difficult intubation
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
420
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee Of North Khorasan University Of Medical Sciences
Street address
Deputy Of Research And Technology, Berenji Line, South Shariati,Bojnurd, Iran
City
Bojnurd
Postal code
Approval date
2012-04-29, 1391/02/10
Ethics committee reference number
90/60/06
Health conditions studied
1
Description of health condition studied
post operative nausea and vomiting
ICD-10 code
Y42.0
ICD-10 code description
Glucocorticoids and synthetic analogues
2
Description of health condition studied
post operatve nausea and vomiting
ICD-10 code
Y43.0
ICD-10 code description
Antiallergic and antiemetic drugs
Primary outcomes
1
Description
post operative nausea and vomiting
Timepoint
every 8 hours :first measurement:2 hours after discharge from recovery room and every 8 hours thereafter for the next 24 hours
Method of measurement
ponv scale
Secondary outcomes
1
Description
biochemical laboratory data
Timepoint
once (preoperative)
Method of measurement
blood test
Intervention groups
1
Description
intervention group 1:ondansetron 4mg=4cc,intravenous as stat injection
Category
Treatment - Drugs
2
Description
Control :placebo =normal saline =4cc ,intravenous as stat injectin
Category
Placebo
3
Description
intervention group 2:metoclopramid 4mg=4cc,intravenous as stat injectin
Category
Treatment - Drugs
4
Description
intervention group 3:dexamethason 4mg=4cc,intravenous as stat injectin
Category
Treatment - Drugs
5
Description
intervention group 4:ondansetron 4mg+metoclopramid 4mg=4cc ,intravenous as stat injectin
Category
Treatment - Drugs
6
Description
intervention group 5:
ondansetron 4mg+dexamethason 4mg=4cc,intravenous as stat injectin
Category
Treatment - Drugs
7
Description
intervention group 6:
metoclopramid 4mg+dexamethason4mg=4cc,intravenous as stat injectin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr Sabermoghadam
Street address
Imam Ali Hospital, Shahriar Street -
City
Bojnurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
North Khorasan University Of Medical Sciences
Full name of responsible person
Saber Raeghi
Street address
Berenji Line, South Shariati
City
Bojnurd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North Khorasan 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
North Khorasan University of Medical Sciences, Bojnurd, Iran
Full name of responsible person
Dr Sabermoghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahriar Street
City
Bojnurd
Postal code
Phone
+98 58 4229 6965
Fax
Email
sabermoghadam41@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences, Bojnurd, Iran
Full name of responsible person
Dr Sabermoghadam,
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahriar Street,
City
Bojnurd
Postal code
Phone
+98 58 4229 6965
Fax
Email
sabermoghadam41@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)