The purpose of this clinical trial study will be investigated the effect of intravenous warm fluids on surgery shivering and core temperature in patients undergoing abdominal surgery. Seventy non-emergency patient candidate for abdominal surgery referring to operating room of educational hospital (Tohid and Bessat) of Kurdistan University of Medical Sciences investigates in Intervention (n=35) and Control (n=35) groups. The first method of study explores for patients that have inclusion criteria, consent form completed, and randomized to intervention or control groups. Demographic characteristic of patients, Central temperature, arterial oxygen saturation (SPO2), and Systolic and Diastolic pressure, Pulse will measure just in entering the recovery room after surgery. Psychrometer and thermometer model TES made by Taiwan will use. Patients in the intervention group will receive intravenous warm fluids (Ringer) 38 C checked by Warmer. After surgery during entering into recovery room Psychrometer and thermometer will use and patients will receive 5 liter O2 by mask, same kind of blanket used for all patients and monitored. Surgery shivering, core temperature, SPO2, Systolic and Diastolic pressure, Pulse will measure just entering the recovery room and after 30 Min.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601163311N2
Registration date:2016-04-10, 1395/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-10, 1395/01/22
Registrant information
Name
Sina Valiee
Name of organization / entity
Kurdistan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1226 7525
Email address
valiee@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-05-01, 1395/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of intravenous warm fluids on surgery shivering and core temperature in patients undergoing abdominal surgery
Public title
Effect of intravenous warm fluids on surgery shivering and core temperature in patients undergoing abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing abdominal surgery; Volunteer for research participation; Non-emergency surgery; Term (37-42 week) pregnancy in cesarean surgery; General or spinal anesthesia; Lack of corticosteroids; NSAIDs; Lack of Magnesium sulfate; Lack of Antihypertensives drugs; Lack of Endocrine disease; Lack of Vascular disease; Lack of Thyroid disease; Lack of Hypertension; Lack of Fever; Lack of addiction
Exclusion criteria:
Blood transfusion during surgery; Hypotension during surgery; Patient dissuasion
Age
From 18 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)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Kurdistan, Iran.
City
Sanandaj
Postal code
66177-13446
Approval date
2015-11-02, 1394/08/11
Ethics committee reference number
MUK.REC.1394.1394/210
Health conditions studied
1
Description of health condition studied
surgery shivering
ICD-10 code
T88.5
ICD-10 code description
Hypothermia following anaesthesia
Primary outcomes
1
Description
Shivering
Timepoint
Just entering recovery room and after 30 Min
Method of measurement
CROSSLEY AND MAHAJAN Scale
2
Description
Core temperature
Timepoint
Just entering recovery room and after 30 Min
Method of measurement
Tympanic Thermometer
Secondary outcomes
1
Description
SPO2, Systolic and Diastolic pressure, Pulse
Timepoint
Just entering recovery room and after 30 Min
Method of measurement
Pulse oximeter, Sphygmomanometer
Intervention groups
1
Description
Intervention group:
Patients in intervention group will received warm fluids (Ringer serum) 38 Celsius after warming and checking by Warmer
Category
Prevention
2
Description
Control group: Patients in control group will received fluids (Ringer serum) with temperature same as room
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences
Full name of responsible person
Sina Valiee
Street address
Kurdistan University of Medical Sciences, Pasdaran St
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mohammad Raman Moloudi
Street address
Kurdistan University of Medical Sciences, Pasdaran St
City
Sanandaj
Grant name
11-8-1394-48319-14
Grant code / Reference number
11-8-1394-48319-14
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Sina Valiee
Position
PhD of Nursing, Assistant Professor
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3316 7525
Fax
Email
sinavaliee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Sina Valiee
Position
PhD of Nursing, Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3316 7525
Fax
Email
sinavaliee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Sina Valiee
Position
PhD of Nursing, Assistant professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3316 7525
Fax
Email
sinavaliee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)