Determining and comparing the effect of two different marcaine temperatures on shivering during and after cesarean section
Design
Patients are randomly divided into two groups of 32 using a table of random numbers:
Marcaine receiving group stored at operating room temperature (24 ° C) at 2.5 cc
Marcaine receiving group stored at refrigerator temperature (4 degrees) at the rate of 2.5 cc
In order to perform random allocation between the two groups, random alloction software version 1 was used under Windows. First, a sequence of random numbers from 1 to 64 with letters A, B (intervention and control) was prepared by the software. The first eligible participant The number 1 and the last person get the number 64 and based on the list of the type of treatment, it is determined that the clinical trial with a control group with parallel randomized blind groups of phase 4 is performed on 64 patients.
Settings and conduct
The study in the obstetrics and gynecology ward of Shahid Sadoughi Hospital in Yazd will be performed on women candidates for cesarean section.
Participants/Inclusion and exclusion criteria
Entry items:Women candidates for cesarean section in the age range of 20 to 38 years with GA 36 to 40 weeks.
Cases of non-entry: People with local anesthesia, hypersensitivity to amide local anesthesia, history of headache and severe preeclampsia.
Intervention groups
Participants in the study are randomly divided into two groups of 32: in the intervention group, participants will receive marcaine stored at refrigerator temperature (4 degrees) and in the control group, participants will receive marcaine stored at operating room temperature (24 degrees).
Main outcome variables
Shivering from 0 to 4 by a special shivering scale for neuraxial anesthesia defined by Crossley and Mahagan.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210816052206N1
Registration date:2021-12-29, 1400/10/08
Registration timing:registered_while_recruiting
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
marjan chalabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8364
Email address
marjan.chalabi1614@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the effect of two different marcaine temperatures on shivering during and after cesarean section
Public title
Investigation and comparison of the effect of two different marcaine temperatures on shivering during and after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for cesarean section in the age range of 20 to 38 years with GA 36 to 40 weeks.
Exclusion criteria:
People with local anesthesia, hypersensitivity to amide local anesthesia, history of headache and severe preeclampsia.
Age
From 20 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random allocationation software version 1.0 under Windows, we generate a random sequence by a simple random allocation method.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to perform random allocation between the two groups, random alloction software version 1 was used under Windows. First, a sequence of random numbers from 1 to 64 with letters A, B (intervention and control) was prepared by the software. The first eligible participant The number 1 and the last person take the number 64 and it is determined based on the list of the type of treatment of the person. In order for the random allocation to be blind, the random allocation list is given to another person who is not involved in the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.SSU.MEDICINE.REC.
Street address
Alam Square, Shohadaye gomnam Boulevard,Shahis sadoughi University of medical Science, Yazd , Iran
City
YAZD
Province
Yazd
Postal code
8916885346
Approval date
2021-11-09, 1400/08/18
Ethics committee reference number
1400.300
Health conditions studied
1
Description of health condition studied
Shivering during and after cesarean section
ICD-10 code
R00–R99
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Shivering
Timepoint
During cesarean section until the end of the patient's recovery time
Method of measurement
Specific shivering scale for neuraxial anesthesia as defined by Grassley and Mahagan 0: No chills, 1: No muscle activity is visible but there is flexibility or contraction of peripheral arteries or both 2: Muscle activity in only one muscle group 3: Moderate muscle activity in more than one muscle group but no overall vibration 4: Activity Intense muscles that involve the whole body
Secondary outcomes
1
Description
Central body temperature
Timepoint
Every 5 minutes from the beginning of cesarean section for the first 20 minutes, then every 10 minutes to 30 minutes, and finally every 15 minutes until the end of the recovery time
Method of measurement
OMRON brand tympanic thermometer
2
Description
Sensory block surface
Timepoint
Every 5 minutes from the start of cesarean section for the first 20 minutes and then every 10 minutes to 30 minutes
Method of measurement
PINPRICK test
3
Description
Hemodynamic variables
Timepoint
Every 5 minutes from the beginning of cesarean section for the first 20 minutes, then every 10 minutes to 30 minutes, and finally every 15 minutes until the end of the recovery time
Method of measurement
Blood pressure and heart rate monitor
4
Description
Nausea and vomiting
Timepoint
5 minutes after the start of cesarean section until the end of the recovery time
Method of measurement
Sick symptoms
5
Description
Need an analgesic supplement
Timepoint
5 minutes after the start of cesarean section until the end of the recovery time
Method of measurement
Request the patient to receive an analgesic supplement according to the symptoms
Intervention groups
1
Description
Women candidates for cesarean section in the age range of 20 to 38 years with GA36 up to 40 weeks under anesthesia with marcaine stored in the refrigerator
Category
Prevention
2
Description
Control group: Women candidates for cesarean section in the age range of 20 to 38 years with GA36 up to 40 weeks under anesthesia with marcaine stored at operating room temperature
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
اتاق عمل کوثر بیمارستان شهید صدوقی یزد
Full name of responsible person
مرجان چلبی
Street address
ایران یزد میدان کاج خیابان ایثار خیابان بهاران کوچه بهاران ۱۴ پلاک ۱۴