The effect of preoperative intravenous ondansetrone for prevention of postoperative shivering in patients undergoing gynecologic surgeries with remifentanil-propofol anesthesia
Prevention of intra and post spinal shivering in cesarean section
Design
This study is a clinical trial study with control group with parallel, double blind and randomized groups.100 women undergoing elective surgery who referred to al-Zahra hospital for surgery Will be examined.The study has two groups of 50 intervention and control group,in the intervention group, 50 women will receive 8 mg Ondansetron and the control group consisted of 50 women who received the same amount of intravenous normal saline .
Settings and conduct
In this study, patients, clinical caregivers, and data analyzers will not aware of grouping.100 women undergoing elective surgery who referred to al-Zahra hospital for surgery Will be examined.The study has two groups of 50 intervention and control group,in the intervention group, 50 women will receive 8 mg Ondansetron and the control group consisted of 50 women who received the same amount of intravenous normal saline and patient's shivering will be examined within 30 minutes in the recovery.Using four scales, the patient's shivering will be assessed .All scales will be treated primarily with warm Baptos and if shivering is sustained, pethidine will be treated.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Patients with American Society of Anesthesiology (ASA) physical status I or II
Exclusion criteria :
Patients with ASA class III or higher ;
Patients with cardiopulmonary diseases ;
Preoperative fever;
Age range under 25 and over 70 years;
Addicted patients.
Intervention groups
Intervention group: 8 mg ondansetron will be injected before anesthesia begins.
Control group:8 mg normal saline will be injected intravenously before the anesthesia begins.
Main outcome variables
Vital Signs(blood pressure, heart rate)
Arterial blood oxygen saturation
Need for pethidine
shivering
Any potential complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121209011700N10
Registration date:2019-10-21, 1398/07/29
Registration timing:registered_while_recruiting
Last update:2019-10-21, 1398/07/29
Update count:0
Registration date
2019-10-21, 1398/07/29
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative intravenous ondansetrone for prevention of postoperative shivering in patients undergoing gynecologic surgeries with remifentanil-propofol anesthesia
Public title
The effect of ondansetrone for prevention of shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with American Society of Anesthesiology (ASA) physical status I or II
Exclusion criteria:
Patients with ASA class III or higher
Patients with cardiopulmonary diseases
Preoperative fever
Use of any anti pyretic or anti-inflammatory medication
Age range under 25 and over 70 years
Addicted patients
Age
From 25 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 25 units of 4 blocks will be selected so that we consider having 50 people in control group (A) and 50 people in intervention group (B). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, clinical caregivers, and data analyzers will not aware of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.TBZMED.REC.1398.571
Health conditions studied
1
Description of health condition studied
Postoperative shivering
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low environmental temperature
Primary outcomes
1
Description
Shivering due to anesthesia
Timepoint
immediate after the intervention, after 5 minute, after 10 minute, after 20 minute, after 30 minute, ...
Method of measurement
PAS(five point rating scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 mg ondansetron will be injected before anesthesia begins.
Category
Prevention
2
Description
Control group:8 mg normal saline will be injected intravenously before the anesthesia begins.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr .Farnaz Moslemi
Street address
Al-Zahra Hospital ,Sought Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemifa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Joyban
Street address
Vice chancellor for research, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr .Farnaz Moslemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital ,Sought Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemifa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr .Farnaz Moslemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital ,Sought Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemifa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr .Farnaz Moslemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital ,Sought Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemifa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD, IPD collected for the primary outcome measure are to be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Seyed Hadi Saghaleini Sina Hospital Azadi Street, Sina Hospital, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 41 35412101 Fax+98 41 35412101 hsaghaleini@gmail.com
What processes are involved for a request to access data/document