The comparison effects of three methods:Pethidine, warm intravenous fluids and combination warming (warm intravenous fluids with humid warm oxygen) on severity of postoperative shivering
The purpose of this study is to compare three methods of using Pethidine, warm intravenous fluids and combined warming(Intravenous fluids with humid warm oxygen) on the severity of postoperative shivering in general anesthesia. Patients was scheduling in class 1 and 2 Society of Anesthesiology America (ASA) under GA abdominal surgery and entering the recovery room and have shivering with 1, 2, 3 degree will be selected. This study is a randomized controlled trial that will be implemented on 96 abdominal surgery patient with general anesthesia .it will be double blind.at first will be appointed the degree of shivering patient in recovery room and patient will be set in randomize three groups . Intravenous Pethidine 0.4mg/kg accompany with room temperature ringer serum and humid- room temperature oxygen will be used for Group 1 ,for group two will be used 38 ° C ringer serum amount 3cc/kg every 10minutes to 20 minutes accompany with humid- room temperature oxygen and placebo(3cc normal salin0.9%) and for group three will be used combination warming(38 ° C ringer serum and humid warm oxygen amount 8lit/min with mask accompany with placebo) .the degree of shivering and tympani c temperature and time of stop shivering will be recorded after use every methods at 10 and 20 minutes .and will be compared groups in end.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012016278N1
Registration date:2014-06-25, 1393/04/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-25, 1393/04/04
Registrant information
Name
Ayob Akbari
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1225 8275
Email address
akbari_ayob@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effects of three methods:Pethidine, warm intravenous fluids and combination warming (warm intravenous fluids with humid warm oxygen) on severity of postoperative shivering
Public title
The comparison effects of pethidine, warm intravenous fluids and combination warming (warm intravenous fluids with humid warm oxygen) on severity of postoperative shivering by general anesthesia patients in recovery room
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:operation under general anesthesia؛ individuals 20-60years؛ the category of America Society of Anesthesiology (ASA) are class 1 and 2, ASA1 ( people with normal health without systemic diseases such as heart disease and respiratory and endocrine and... ) ASA2 ( people that have a mild controlled systemic disease and not limit the patient) ;degree1,2,3 of shivering; normothermic patients :the oral temperature will be between 36/5 to 37/5° C ;the lack of reception ( corticosteroids, non steroidal analgesics , anti hypertensive drugs , anti seizure drugs); lack of received blood and blood products;patient without BP and SPO2 changes;consent to participate up to the end study.
Exclusion criteria :spinal anesthesia;individuals below20 and up 60 years ; ASA 3,4 such as( endocrine disorders , cardiovascular diseases , hypertension, ischemic heart disease , obstructive lung disease and cerebral palsy patient and... ) ;fever;addiction;hyperthermia and hypothermia; reception( corticosteroids, non steroidal analgesics , anti hypertensive drugs , anti seizure drugs); received blood and blood products ; degree 4 of shivering ;patients who will not consent to participate up to the end study ; patients with BP changes are more 5mm/ hg ;decrease in spo2 than 15%.
Age
From 19 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Birjand University of Medical Sciences
Street address
Central Organization of Birjand University of Medical Sciences and Health Services, Ghaffari Street, Birjand, South Khorasan
City
Birjand
Postal code
۴۴۳۰۰۷۶
Approval date
2014-05-04, 1393/02/14
Ethics committee reference number
1393-02-03
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
T80-T88
ICD-10 code description
Complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Shivering
Timepoint
Postoperative
Method of measurement
Patient Observation
Secondary outcomes
1
Description
Temperature
Timepoint
Postoperative
Method of measurement
Tympanic thermometer
Intervention groups
1
Description
combination warming(intravenous warming serum and humid warm oxygen 8lit/min)
Category
Treatment - Drugs
2
Description
warm intravenous fluids(38 ° C ringer serum)
Category
Treatment - Drugs
3
Description
intravenous pethidin 0.4mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr.Ahmad Ali Nasiri Forg
Street address
Emam Raza Hospital, Taleghani Street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Dr.Ahmad Ali Nasiri Forg
Street address
Central Organization of Birjand University of Medical Sciences and Health Services, Ghaffari Street, Birjand, South Khorasan
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Science
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
Birjand University of Medical Sciences
Full name of responsible person
Ayob Akbari
Position
Master of Nursing
Other areas of specialty/work
Street address
Orthopedic ward, Emam reza Hospital, Taleghani street, Birjand, South Khorasan
City
Birjand
Postal code
9713915333
Phone
+98 56 1225 8275
Fax
+98 56 1222 6898
Email
akbari_ayob@bums.ac.ir armin_623@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Central Organization of Birjand University of Medical Sciences and Health Services, Ghaffari Street,
Full name of responsible person
Dr.Ahmad Ali Nasiri Forg
Position
Phd of nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
9713915333
Phone
+98 56 1225 8275
Fax
+98 56 1222 6898
Email
nasiri2006@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ayob Akbari
Position
Maseter of Nursing
Other areas of specialty/work
Street address
Orthopedic Ward, Emam reza Hospital, Taleghani street, Birjand, South Khorasan
City
Birjand
Postal code
9713915333
Phone
+98 56 1225 8275
Fax
+98 56 1222 6898
Email
akbari_ayob@bums.ac.ir armin_623@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)