A comparative study of the prophylactic effect of intravenous dexamethasone and meperidine on shivering in patients undergoing cesarean section with spinal anesthesia
Determining the prophylactic effect of intravenous dexamethasone and meperidine on shivering in patients undergoing cesarean section with spinal anesthesia
Design
Spinal anesthesia will be performed in the L4-L5 spinal interspaces in the sitting position with 2.5 ml of half point percent hyperbaric bupivacaine with a concentration of 5 mg/ml through a Quincke 26G spinal needle and in the paramedian way. All drugs will be provided as coded syringes by an anesthesiologist blinded to group allocation. All three groups of cases and control will receive intravenous dexamethasone, meperidine and isotonic saline as these mentioned before . the incidence and degree or absence of shivering will be noted and study.
Settings and conduct
Shahid Beheshti educational and therapeutic center
Participants/Inclusion and exclusion criteria
Inclusion criteria:: Patients whose are candidate for cesarian section in Shahid Beheshti hospital
Exclusion criteria: Cardiopulmonary, liver or kidney disease, mental disorders, diabetes mellitus, thyroid disorder, admission temperature lower than 36.5 and higher than 37.5, known history of alcohol or drug use.
Intervention groups
intervention group 1: dexamethasone 2 mg intravenous in 2 cc un specified syringe.
intervention group 2:meperidine 0.3 milligram per each kilogram of body weight intravenous in 2 cc un specified syringe.
control group: 2 cc isotonic saline in 2 cc un specified syringe.
Main outcome variables
shivering severity, shivering incidence.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240221061070N1
Registration date:2024-04-15, 1403/01/27
Registration timing:registered_while_recruiting
Last update:2024-04-15, 1403/01/27
Update count:0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
Milad Masaeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 106 6709
Email address
drmilmas@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the prophylactic effect of intravenous dexamethasone and meperidine on shivering in patients undergoing cesarean section with spinal anesthesia
Public title
comparison dexamethasone and meperidine on shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women
ASA Class 1-2
Elective cesarean
Exclusion criteria:
cardiac disease
pulmonary disease
liver disease
renal disease
psychological disease
diabetes mellitus
thyroid disease
body temperature less than 36.5 Celsius degree
body temperature more than 38.5 Celsius degree
history of alcohol abuse
history of drug abuse
intra operative blood transfusion
analgesic drugs administration
take any drugs effect on body temperature
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized in such a way that numbers 1 to 15 will be placed randomly in three groups A, B, C using the www.random.org website from the Numbers section of the Sequence Generator option. In this way, the grouping of the first 15 eligible patients is determined, for example, if in randomization, the number 14 is in column B, it means that the fourteenth patient who is eligible to enter the study is placed in group B and...
Randomization will be done again for the next 15 patients. This process continues until we reach the desired sample size
Blinding (investigator's opinion)
Triple blinded
Blinding description
To ensure the achievement of the study objective, the patients, anesthetist, and investigators blind to the treatment group; moreover, the aforementioned individuals do not aware of the type of injectable medication and the intrathecal injections prepare with same anesthesiologist. (the preparation of the injectable medications named A and B and C conduct by the researcher).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Al-Zahra Hospital, Daneshgah Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-02-21, 1402/12/02
Ethics committee reference number
IR.MUI.MED.REC.1402.441
Health conditions studied
1
Description of health condition studied
post surgical shivering
ICD-10 code
O74.9
ICD-10 code description
Complication of anesthesia during labor and delivery, unspecified
Primary outcomes
1
Description
shivering incidence
Timepoint
0,5,10,15,30,45,60,90(min)
Method of measurement
Based on shivering in the patient based on the patient's expression or muscle contraction
2
Description
shivering severity
Timepoint
0،5،10،15،30،45،60،90(min)
Method of measurement
Zero degree: no shivering, Grade 1: Peripheral vasoconstriction, but without visible shivering. Second degree: muscle activity in only one muscle group. Grade 3: Muscle activity in more than one muscle group, but not generalized. Fourth degree: trembling that involves the whole body
Secondary outcomes
1
Description
Blood pressures
Timepoint
0،5،10،15،30،45،60،90(min)
Method of measurement
Non invasive couphmetr
2
Description
Room temperature
Timepoint
0،5،10،15،30،45،60،90(min)
Method of measurement
E.SUN thermometer
3
Description
Core temperature
Timepoint
0،5،10،15،30،45،60،90(min)
Method of measurement
In the inner ear area (using the tympanic membrane thermometer, which is considered the average core temperature and the GENTLE TEMP 520 thermometer from OMRON company)
Intervention groups
1
Description
Intervention group: first.2 milligram intra venous dexamethasone in un specified 2 cc syringe. From 8 mgr vial of Dexamethasone and single injection
Category
Treatment - Drugs
2
Description
Intervention group: second.0.3 milligram per each kilogram of body weight intra venous meperidine in un specified 2 cc syringe. single injection
Category
Treatment - Drugs
3
Description
Control group: third.2 cc intra venous isotonic saline in un specified 2 cc syringe.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti educational and therapeutic center
Full name of responsible person
Milad Masaeli
Street address
Shahid Motaharri
City
Isfahan
Province
Isfehan
Postal code
81848-53541
Phone
+98 31 3236 7001
Email
drmilmas@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Asgari
Street address
Research and Technology Vice-Chancellor, No. 4 Building, Isfahan University of Medical Sciences and Health care Service, Hazar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Apposite of Asman Hotel, The beginning of Shahid Motahari St, Felezzi Bridge, Isfahan
City
Esfahan
Province
Isfehan
Postal code
81848-53541
Phone
+98 31 3236 7001
Email
drmilmas@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad MASAELI
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Apposite of Asman Hotel, The beginning of Shahid Motahari St, Felezzi Bridge, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
81848-53541
Phone
+98 31 3236 7001
Email
drmilmas@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Apposite of Asman Hotel, The beginning of Shahid Motahari St, Felezzi Bridge, Isfahan.
City
اصفهان
Province
Isfehan
Postal code
81848-53541
Phone
009-31-3236-7001
Email
drmilmas@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
these data are private
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all data except of name and private data of patients
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
Academic researchers by the reason
Under which criteria data/document could be used
If it is for scientific purposes.
From where data/document is obtainable
Send a message to drmilmas@gmail.com and after presenting your reasons, the information you need will be sent.
What processes are involved for a request to access data/document
Send a message to drmilmas@gmail.com and after presenting your reasons, the information you need will be sent.