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Effect of Granisetron in prevention of shivering after spinal anesthesia in lower Abdominal Surgery

Protocol summary

Summary
The aim of this study is to determine the effect of granisetrone in prevention of post spinal anesthesia shivering. In a randomized clinical trial 105 patients with age 18-60 yr and American society of anesthesia (ASA) class 1-2 who have undergo in lower abdominal surgery randomly allocate in three groups. Group A receive 1 mg intravenous granisetrone, group B 3 mg intravenous granisetrone and group C five ml normal saline intravenously. Before induction of spinal anesthesia, the prepared solutions will be administered intravenously. Same spinal anesthesia at L2-L3 or L3-L4 level will be used in all patients. Bupivacain 0.5% with dose 10-14 mg will be used. No sedative or narcotic will be use after spinal anesthesia. During surgery and recovery, patients will be monitored for shivering, pain, hemodynamic alteration and other complications. During surgery and at post operative care unit, patients will be covered. Oxygen will be administered by face mask for all patients and they will be monitored. Anesthesiologist who is not aware about patients groups, will record the shivering, nausea, vomiting and pain. In addition, any other complications such as hemodynamic alteration will be record. In addition to oxygen therapy, patients with shivering will be warmed.In patients who have shivering with grade 3 or more , petidine (25 mg IV) every 20 minute in maximum three doses will be used

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411203915N14
Registration date: 2014-12-09, 1393/09/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-09, 1393/09/18
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
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
Effect of Granisetron in prevention of shivering after spinal anesthesia in lower Abdominal Surgery
Public title
Effect of Granisetron in prevention of shivering after spinal anesthesia in lower Abdominal Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ages 18-60 yr; American society of anesthesia (ASA) class 1-2; elective inguinal hernia repair with spinal anesthesia. Exclusion criteria: patients refuse of spinal anesthesia; any contraindication for regional anesthesia.
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: 105
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
9384

Health conditions studied

1

Description of health condition studied
Shivering after regional anesthesia
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 : Administration of intavenous granisetrone 1mg before spinal anesthesia
Category
Treatment - Drugs

2

Description
Group B: Administration of intravenous granisetrone 3 mg befor spinal anesthesia
Category
Treatment - Drugs

3

Description
group C: Administration of intravenous saline normal 5 ml before spinal 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 Abasali Dehghani
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
dehghania@tbzmed.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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