Patients will randomly assign into two equal groups for spinal anesthesia according to numbers inserted in sealed envelopes. Before performing the spinal anesthesia, patients will be under standard monitoring and receive IV lactated Ringer’s solution 10 ml/kg. During anesthesia, oxygen is given, and patients will cover with drapes but not actively be warm. All fluids will warm to 37°C. The patients will divide equally into two groups. (n=39). Group A heavy cold bupivacaine up to 2 milliliter plus 10 micrograms of fentanyl, Group B warm bupivacaine up to 2 milliliter plus 10 micrograms of fentanyl, Spinal anesthesia will perform in sitting position at the L4-5 inter space with a mid line approach by using a 25-gauge Quincke needle. Solutions prepare by another anesthesiologist so that the anesthesiologist performing the spinal block is blind of which drug will be injected. After spinal injection, parturient will be placed supine with left uterine displacement. Shivering and other data
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106271936N6
Registration date:2011-06-29, 1390/04/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-06-29, 1390/04/08
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study Between the effect of cold and warm Intra techal Bupivacaine on shivering in caesarian surgery
Public title
Comparative Study Between the effect of cold and warm Intra techal Bupivacaine on shivering in caesarian surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parturient (ASA physical status I or II) age between 18 till 40 scheduled for no emergent cesarean delivery under spinal anesthesia and signing the informed consent
Exclusion criteria:
Contraindications to regional anesthesia; hypersensitivity to amide local anesthetics; history of headache and severe preeclampsia
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Siraf avenue
City
Bushehr
Postal code
Approval date
2010-12-08, 1389/09/17
Ethics committee reference number
34454/3/18/20/دپ
Health conditions studied
1
Description of health condition studied
Shivering afer spinal anesthesia
ICD-10 code
O74.9
ICD-10 code description
Complication of anaesthesia during labour and delivery, unspecified
Primary outcomes
1
Description
Post operative shivering
Timepoint
Till 120 mimute after surgery
Method of measurement
Observation
Secondary outcomes
1
Description
Nausea and vomiting after surgery
Timepoint
Till 120 minutes after surgery
Method of measurement
Observation
Intervention groups
1
Description
Warm bupivacaine(amid local anesthetic) that hold(in the room) out of refrigerator (%0/5) up to 2 milliliter will be injected Intratechaly once
Category
Prevention
2
Description
Cold bupivacaine(amid local anesthetic) that holdin the refrigerator (%0/5) up to 2 milliliter will be injected Intratechaly once
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bentolhoda hospital
Full name of responsible person
Dr Najafi Anaraki
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research committee of medical science
Full name of responsible person
Dr. Asadi
Street address
School of Medicine, Bushehr University of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research committee 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 1354 0088
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)