Due to the effectiveness of warm intravenous fluids to prevent perioperative hypothermia and thus reduce the shivering caused by hypothermia and considering the importance of controlling postoperative shivering, we decided to study the effectiveness of intravenous warm fluids in the prevention of shivering after ENT surgery. In a double blind randomized controlled clinical trial, 70 patients undergoing ENT surgery will be divided into 2 groups including one receiving of heated fluids (37 ° C) and one receiving liquids at operation room temperature and the core tympanic membrane temperature and postoperative shivering while recovery will be recorded.
Patients premedication in both 2 groups will be Similar and General anesthesia will be started with Propofol 2 mg / kg and Atracurrium 0.6 mg / kg and for maintenance of anesthesia after intubation 50% of Nitros Oxaid and oxygen and Isoflurane 0.7-1 % and infusion 5-8 μg /kg of Remifentanil will be used. Nasopharyngeal temperature will be recorded using a probe that will be placed through nose after anesthesia induction and will be kept in place until extubation. Primary variable is shivering and secondary variable is O2 saturation. Patients will be monitored for one hour in recovery room and post operational shivering and O2 saturation will be recorded .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609284005N12
Registration date:2016-10-30, 1395/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Khosro Kolahdouzan
Name of organization / entity
Faculty of Paramedical Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 4777
Email address
kolahdozank@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of warming intravenous fluids on post operative shivering during ENT surgery
Public title
The effects of warming intravenous fluids on post operative shivering during surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing ENT surgeries ; with ASA I orII ; between the ages of 25-70 years old.
exclusion criteria: hypothermia ;hypertermia ;renal failure ;heart failure ;otitis medial
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2016-08-29, 1395/06/08
Ethics committee reference number
1395.628.IR.TBZMED.REC
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Shivering
Timepoint
Every10 minute for1 hour after recovery
Method of measurement
Probe for nasopharynx temperture
Secondary outcomes
1
Description
O2 Saturation
Timepoint
Every 10 minitue for 1 hour after recovery
Method of measurement
Capnograph
Intervention groups
1
Description
Control groups receiving liquids at operation room temperature
Category
Treatment - Drugs
2
Description
Intervention group receiving heated fluids (37 ° C)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Mahmoud Eidy
Street address
Emam reza hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice Chancellor of Research,Tabriz university of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
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
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
Emam Reza Hospital
Full name of responsible person
Dr Mahmoud Eidy
Position
Professor of Anesthesia
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
eidy@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahmoud Eidy
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
eidy@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosro Kolahdouzan
Position
Masters of Anesthesiology
Other areas of specialty/work
Street address
Paramedicine Faculty
City
Tabriz
Postal code
Phone
+98 413348573
Fax
Email
kolahdozank@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)