Comparison of the Effectiveness of Prophylaxic Two Different Doses of Dexmedetomidine in Prevention of Shivering During Regional Anesthesia in Cesarean Section
The Survey of Prophylaxic Two Different Doses of Dexmedetomidine in Prevention of Shivering During Regional Anesthesia in Cesarean Section
Design
This study was conducted in parallel ,double-blind,randomized,60 patients who were in the phase 3 trial were designed.
Settings and conduct
Pregnant women referred to Alzahra Hospital and Shahid Beheshti Hospital who underwent spinal anesthesia were divided into three random groups. The first group received 2.5 μg / kg dexmedetomidine
The second group received 5 μg / kg dexmedetomidine and the third group received normal saline. Clinical participant, evaluator and analyzer do not understand type of drug and after decoding b, a and c code is decoded by researcher
Participants/Inclusion and exclusion criteria
Enclusion criteria :1-Pregnant women in the age range18-45
2- Anesthesiologists American Society of (ASA)) degree2and3 candidate for cesarean section
3-Patient consent to participate in the study
Exclusion criteria:En A history of hypersensivity to alpha adrenergic drug- Liver Patients -Bradycardy history -2nd or 3nd degree AV block Vascular problems- Type 2 diabetes- Hyopvolemia- Taking vasodilator or medications that change the body's central temperature- Drug use
Intervention groups
Informed consent was obtained from the parents of the patients first. After the patients were placed on the operating bed and after connecting standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs, then the intervention group A received2.5 μg / kg dexmedetomidine and Intervention group B received 5 μg / kg dexmedetomidine and the control group received normal saline syringe.
Main outcome variables
Shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N17
Registration date:2020-03-19, 1398/12/29
Registration timing:retrospective
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-02, 1398/11/13
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Prophylaxic Two Different Doses of Dexmedetomidine in Prevention of Shivering During Regional Anesthesia in Cesarean Section
Public title
The Survey of Prophylaxic Two Different Doses of Dexmedetomidine in Prevention of Shivering During Regional Anesthesia in Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in the age range18-45
2- Anesthesiologists American Society of (ASA)) degree2and3 candidate for cesarean section
Patient consent to participate in the study
Exclusion criteria:
A history of hypersensivity to alpha adrenergic drug
Liver Patients
Bradycardy history
2nd or 3nd degree AV block
Vascular problems
Type 2 diabetes
Hyopvolemia
Taking vasodilator or medications that change the body's central temperature
Drug use
Age
From 18 years old to 45 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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to three groups A, B, C using the Random Allocation computer
software
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are prepared in one form and in the form of a volume in the syringe by the researcher, and the
hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the evaluator and data analyser do not understand the type of medication and the investigator deciphers the codes after data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.MUI.MED.REC.1398.558
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering
Timepoint
Recovery Duration
Method of measurement
Using the Grassi and Mahajan criterion
2
Description
Central temprature
Timepoint
At he base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Tympanic thermometer
3
Description
Temperature of Peripheral
Timepoint
At he base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Thermometer Skin
4
Description
The level of sedation
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Using the Ramsay Sedation Scale
5
Description
Severity of Pain
Timepoint
At of recovery. the base time; after the procedure and then every 15 minutes until discharge
Method of measurement
Using the Visual Analogue Scale
6
Description
Systolic blood pressure
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Non invasive blood pressure measurement
7
Description
Diastolic blood pressure
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery
Method of measurement
Non invasive blood pressure measurement
8
Description
Oxygen saturation
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery
Method of measurement
Pulse oximetry device
9
Description
Heart Rate
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Heart monitoring device
10
Description
Mean Arterial Blood Pressure
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Non invasive blood pressure measurement
11
Description
Duration of stay in recovery
Timepoint
From recovery admission to recovery discharge
Method of measurement
Watch or clock
Secondary outcomes
1
Description
Nausea
Timepoint
Duration of stay in recovery
Method of measurement
Questionnaire
2
Description
Vomiting
Timepoint
Duration of stay in recovery
Method of measurement
Questionnaire
3
Description
Itching
Timepoint
Duration of stay in recovery
Method of measurement
Questionnaire
4
Description
Usage of Atropine
Timepoint
From the beginning of the opration to the end of recovery
Method of measurement
Anesthesia Technician Asked About Drug Use
5
Description
Usage of Pethidine
Timepoint
Duration of stay in recovery
Method of measurement
Anesthesia Technician Asked About Drug Use
6
Description
Usage of Ephedrine
Timepoint
From the beginning of the opration to the end of recovery
Method of measurement
Anesthesia Technician Asked About Drug Use
Intervention groups
1
Description
Intervention group A: informed consent from patients first. After patients are placed on operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs Group A = 2.5 μg / kg intravenous dexmedetomidine Is given immediately after induction of anesthesia, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times.
Category
Prevention
2
Description
Intervention groupB: informed consent from patients first. After patients are placed on operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs Group A = 5μg / kg intravenous dexmedetomidine Is given immediately after induction of anesthesia, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times.
Category
Prevention
3
Description
Control group: informed consent from patients is first obtained. After placing the patients on the operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs are recorded. Intravenous saline is given immediately after induction of anesthesia and moderate arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired time.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Behzad Nazemroaya
Street address
West Shahid Motahari Street
City
Isfahan
Province
Isfehan
Postal code
8184851153
Phone
+98 31 3236 7001
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghyegh Haghjoo
Street address
Hezar Jarib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Samira Heydari
Position
Medical student/Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr Street
City
Khorzouq
Province
Isfehan
Postal code
8345154611
Phone
+98 31 4540 6714
Email
samiraheydari2525@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samira Heydari
Position
Medical student/Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr Street
City
Khorzouq
Province
Isfehan
Postal code
8345154611
Phone
+98 31 4540 6714
Email
samiraheydari2525@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available