The aim of this study is to determine the effect of different doses of Granisetron on preventing post-operative shivering in septoplasty patients. In a randomized clinical trial 90 patients with age 18-60 yr and ASA class 1-2 who have elective septoplasty randomly allocate in three groups. Group A receive 1 mg granisetrone, group B 3 mg and group C 5 ml normal saline. Before induction of general anesthesia, the prepared solution will be administered intravenously. Same standard general anesthesia will be used in all patients. All patients will be monitored according to ASA standards. In PACU all patients will be covered with blanket and receive oxygen by face mask and will be monitored. Anesthesiologist who is not aware about patients group, will record the shivering, nausea, vomiting and pain. In addition any other complications such as hemodynamic alteration will be record. In patients with shivering, In addition to o2 therapy, they will warm and in patients with shivering grade 3 or more petidine (25mg IV) every 20 minute in maximum 3 doses will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411173915N11
Registration date:2014-12-04, 1393/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-04, 1393/09/13
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor for Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different doses of Granisetron on preventing postoperative shivering in patients undergoing septoplasty under general anesthesia
Public title
The effect of different doses of Granisetron on preventing post-operative shivering in septoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18-60 yr; ASA class 1-2; elective septoplasty surgery.
Exclusion criteria: cardio-respiratory diseases; infections; body temperature less than 36.5˚C and more than 38˚C; allergy to serotonin antagonist drugs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Golgasht street
City
Tabriz
Postal code
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
9366
Health conditions studied
1
Description of health condition studied
Shivering after septoplasty
ICD-10 code
Y40-Y84
ICD-10 code description
Complications of medical and surgical care
Primary outcomes
1
Description
Post operative shivering
Timepoint
Till 2 hours after surgery
Method of measurement
Clinical assessment
Secondary outcomes
1
Description
Need for petidine administration
Timepoint
Till 2 hours after surgery
Method of measurement
Clinical assessment
Intervention groups
1
Description
Group A: intravenous granisetrone 1 mg diluted with 5 ml saline normal before induction of general anesthesia
Category
Treatment - Drugs
2
Description
Group B: intravenous granisetrone 3 mg diluted with 5 ml normal saline before induction of general anesthesia
Category
Treatment - Drugs
3
Description
Group C: 5 ml intravenous saline normal before induction of general anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Ali Peirovifar
Street address
Golgasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor for Tabriz University of Medical Sciences
Full name of responsible person
Dr Farhoodi
Street address
Golgasht street
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 for 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 Ali Peirovifar
Position
Associate Professor
Other areas of specialty/work
Street address
Operation room. Emam Reza hospital. Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
peirovifara@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 Ali Peirovifar
Position
Associate professor
Other areas of specialty/work
Street address
Operation room.Emam Reza hospital. Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
peirovifara@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)