Protocol summary

Summary
The purpose of this study was to compare Dexamethasone and Metoclopramide in prevention of post- inguinal hernia surgery nausea and vomiting. In a randomized, double-blind clinical trial, 60 ASA class I-II patients, aged 20-40 years old and weight lower than 100kg, undergoing general anesthesia for inguinal hernia Besat hospital were recruited and assigned to receive 10mg Metoclopramide, IV or 8mg Dexamethasone, IV, 10 min before extubation and 6 hours after operation. Nausea and vomiting were measured for 1, 3, and 6 hours after the end of the operation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008254505N1
Registration date: 2010-09-11, 1389/06/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-09-11, 1389/06/20
Registrant information
Name
Rasool Kavyannejad
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 5322 3828
Email address
rasol.kavian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Kordistan Univercity of Medical Sciences
Expected recruitment start date
2010-09-16, 1389/06/25
Expected recruitment end date
2011-09-14, 1390/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of Dexamethasone and Metoclopramide in prevention of post nausea and vomiting after hernia inguinal surgery
Public title
Comparison of Dexamethasone and Methoclopramide on nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: inguinal hernia elective surgery, weight<100kg, age 20-40 years, no severe or chronic illness or (Asthma, Blood pressure, Lung, Renal or liver diseases), having Class ASA I-II Exclusion criteria: hypersensitivity to investigation drugs, No cooperation, Occurrence of heart and lung disorders, Smoking, opium consumption, any drug hypersensitivity
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Kordistan University of Medical Sciences
Street address
Pasdaran Street, Sanandaj, Kordistan
City
Sanandaj
Postal code
Approval date
2007-07-28, 1386/05/06
Ethics committee reference number
2085

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description

Primary outcomes

1

Description
Nausea
Timepoint
1, 3, 6 hours after operation
Method of measurement
Asking the patient and observation

2

Description
Vomiting
Timepoint
1, 3, 6 after operation
Method of measurement
observation and checklist

Secondary outcomes

empty

Intervention groups

1

Description
10mg Metoclopramide IV before extubation and 6 hours after operation
Category
Treatment - Drugs

2

Description
8mg Dexamethasone (IV) before extubation and 6 hours after operation
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Street address
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kordistan University of Medical Sciences
Full name of responsible person
Rasool Kavyannejad
Street address
Pasdaran Street
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kordistan 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
Hamedan University of Medical Sciences
Full name of responsible person
Rasool Kavyannejad
Position
MSc Student
Other areas of specialty/work
Street address
Mahdie Street
City
Hamedan
Postal code
Phone
+98 83 5322 3828
Fax
Email
rasol.kavian@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rasool Kavyannejad
Position
MSc Student of Critical Care Nursing
Other areas of specialty/work
Street address
Mahdie Street
City
Hamedan
Postal code
Phone
+98 83 5322 3828
Fax
Email
rasol.kavian@umsha.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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