The purpose of this study is to compare two methods of using warm intravenous fluids and Hot air Radiant with routine patiens Care on the severity of postoperative shivering,pain,anxiety and spinal anesthesia duration in spinal anesthesiapatiens. Patients was scheduling in class 1 and 2 Society of Anesthesiology America (ASA) under elective cesarean section will be selected. This study is a randomized controlled trial that will be implemented on 75 cesarean delivery surgery patient with spinal anesthesia .it will be double blind. patient will be set in randomize three groups . routine Care(Serum with Equal operation room temperature ) will be used for Group 1 ,for group two will be used intravenous warme serum (37.5 ° C) and for group three will be used Hot air Radiant. the degree of shivering will be recorded in recovery room and tympani c temperature will be recorded from starting of surgery to end of recovery room.pain, nausea and vomiting, post dural headech will be assed in firste 24h. anxiety level will be evaluated pre and postoperation by spielberger anxiety questionnaire. BP,HR and spinal anesthesia duration will be recorded and then compared groups in end.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020232361N1
Registration date:2017-05-27, 1396/03/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Hojjat Torkmandi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 263601135
Email address
torkmandi.or@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
The project funding is provided through Semnan University of Medical Sciences.
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of warm serum and Hot air Radiant on prevention of Headache - nausea and vomiting after cesarean surgery
Public title
Comparison effect of warm serum and Hot air Radiant on post operative complication in cesarean surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include: age between 20–60 years old; undergoing cesarean surgery under spinal anesthesia;and duration of surgery between ./5 and 2 h.
Exclusion criteria include: Having a history of thyroid disease, use of anticholinergic drugs, patients with infection in surgical location, diabetic, emergency surgery; Having a history of headaches,
Patients with very high weight BMI>35, Body Temperature>38 or <36, A history of motion sickness, Received blood products during surgery and emergency surgery.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
----
Secondary trial Id
---
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, 5th Km Damghan road, Semnan, Iran.
City
Semnan
Postal code
35198-99951
Approval date
2016-12-12, 1395/09/22
Ethics committee reference number
IR.SEMUMS.1395.157
Health conditions studied
1
Description of health condition studied
surgical complication of cesarean section
ICD-10 code
Y83.8
ICD-10 code description
Other surgical procedures
Primary outcomes
1
Description
bleeding
Timepoint
Intraoperative
Method of measurement
Weight change gases, and Long gases and blood volume within the botel suction
2
Description
Core temperature
Timepoint
Every 15 minutes , before induction of anesthesia to the end of Recovery
Method of measurement
Using a tympanic thermometer
3
Description
blood pressure
Timepoint
Before Surgery then every 15 minutes to the end of the recovery
Method of measurement
Using cardiac pressure monitoring device
4
Description
shivering
Timepoint
After the intervention in recovery
Method of measurement
Three-point scale of shivering
5
Description
anxiety
Timepoint
Before Surgery- after surgery and then 6-12 and 24 h after surgery
Method of measurement
spielberger anxiety questionnaire
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
Since his arrival in recovery every six hours in first 24h
Method of measurement
Based on the VAS scale
2
Description
The duration of anesthesia
Timepoint
During the injection -end of operation and then every 15 min to complet motor and sensory recovery
Method of measurement
base on Bromage scale
3
Description
pain
Timepoint
every 6h and before analgesics druge Prescription
Method of measurement
base on VAS scale
4
Description
Anxiety
Timepoint
before operation- post operation- 6,12 and 24 h after operation
Method of measurement
base on Spielberger questionnaire
Intervention groups
1
Description
Control group: receiving Serum with Equal operation room temperature and without Hot air Radiant.
Category
Treatment - Drugs
2
Description
The first intervention group: This group of patients recived warm intravenous serum(37.5 degrees) For complet time of surgery and recovery.Heating serum is by Hot Line Manufacturing Co. Hotline® Blood and Fluid Warmer Smiths medical model level1.The device is placed over the head tube and Continuously heats.
Category
Prevention
3
Description
Patients in the intervention group II: This group of similar patients in the control group, except that after entering the recovery room warm air radiation (by heating warm-med making Turkey) to the end of his time in recovery are receiving.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Dr Banafshe moshak
Street address
Kamali Hospital, Shohada square, Karaj
City
karaj
2
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Forozeshfard Mohammad
Street address
Semnan - B basij - Semnan University of Medical Sciences
City
semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
prof. Ali Rashidipoor
Street address
Semnan University of Medical Sciences, End of Basij Avenue, Semnan, Iran.
City
semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hojjat Torkmandi
Position
master of critical care nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5km Damghan road, Semnan, Iran.
City
semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
hojjat.or@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of medical Sciences
Full name of responsible person
Hojjat Torkmandi
Position
master of critical care nursing
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
Torkmandi.or@semums.ac.irhojjat.or@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hojjat Torkmandi
Position
master of critical care nursing
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
Torkmandi.or@semums.ac.irhojjat.or@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)