In this study 183 men who were candidate for orthopedic surgeries, in the range of 16 to 65 years old, were evaluated. These patients are in ASA I and II classes. According to their visit order, they randomly pick a number from 1 to 183, which are in a basket. In order to the numbers they were divided into three equal groups (n=61). The first group took 3 mg Granisetron, the second one took 8 mg Dexamethasone and the third one took 10 mg Metoclopramide intravenous before anesthesia. During 8 hours after operation, nausea and vomiting were evaluated. Both patients and data analysts were unaware of the preoperative medication of each patient in this study. In all patients, the induction of anesthesia was performed with 2.5 mg/kg propofol, 0.6 mg/kg atracurium, 100 mcg fentanyl and 2 mg midazolam. After intubation, anesthesia maintenance was performed with 1.2 MAC isoflurane and O2 (7 lit/min). All patients received 0.1 mg/kg morphine as a long acting analgesic drug. N2O was not used for the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042715281N3
Registration date:2015-11-23, 1394/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-23, 1394/09/02
Registrant information
Name
Seyedebrahim Sadeghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 3278
Email address
esadeghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Committee of Shiraz University of Medical Sciences; International Branch
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic antiemetic effect of Granisetron, Dexamethasone and Metoclopramide in surgical procedures under general anesthesia
Public title
Comparison of prophylactic antiemetic effect of three medicines in surgical procedures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men who were candidate for orthopedic surgeries, in the range of 16 to 65 years -old, were evaluated. The patients who are in ASA I, II classes. Patients who use antiemetic drugs 48 hours before operation and who had post operative nausea and vomiting record in previous surgeries, patients with motion sickness, migraine, diabetes mellitus and smokers were not included.
Exclusion criteria: patients who were discharged immediately after recovery.
Age
From 16 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
183
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Karimkhane zand Blvd. Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2015-03-07, 1393/12/16
Ethics committee reference number
ct-2015-253
Health conditions studied
1
Description of health condition studied
Complications of anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
During 2 hours in recovery and 6 hours in surgical ward
Method of measurement
Fill questionnaire and visual scale
Secondary outcomes
1
Description
Age
Timepoint
Before operation
Method of measurement
Fill questionnaire
2
Description
Weight
Timepoint
Before operation
Method of measurement
Balance
Intervention groups
1
Description
3 mg granisetron intravenous
Category
Prevention
2
Description
8 mg dexamethasone intravenous
Category
Prevention
3
Description
10 mg metoclopramide intravenous
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Marvdasht Shahid Motahhari Hospital
Full name of responsible person
Seyed Ebrahim Sadeghi
Street address
Shahid Motahhari Hospital, Moallem Sq. Marvdasht
City
Marvdasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, International Branch of Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Reza Panjeshahin
Street address
Central Office of International Branch of Shiraz University of Medical Sciences, No 24, Jehad sazandegi st. Azadi Sq. shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, International Branch of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ebrahim Sadeghi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Shahid Motahhari Hospital, Moallem Sq. Marvdasht
City
Marvdasht
Postal code
7371474973
Phone
+98 71 4334 2061
Fax
+98 71 4333 7517
Email
esadeghi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ebrahim Sadeghi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Shahid Motahhari Hospital, Moallem Sq. Marvdasht
City
Marvdasht
Postal code
7371474973
Phone
+98 71 4333 3278
Fax
+98 71 4333 7517
Email
esadeghi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ebrahim Sadeghi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Shahid Motahhari Hospital, Moallem Sq. Marvdasht
City
Marvdasht
Postal code
7371474973
Phone
+98 71 4334 2061
Fax
+98 71 4333 7517
Email
esadeghi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)