Comparison of the effectiveness of intravenous injection of Ketamine and Ondansetron in the prevention of the post-operative shivering in Cesarean Section under spinal anesthesia
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General information
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Adress changing
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تغییر آدرس
تغییر آدرس
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leyle Rafiei
Full name of responsible person - Persian: لیلا رفیعی
Position - English: Nurse Anesthesia
Position - Persian: پرستار بیهوشی
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 223-9, unit.8, Aria bilding, West Kargar Alley, Farabi 3 Ave, Sepahan Shahr
Street address - Persian: سپاهان شهر خیابان فارابی3 کوچه کارگر غربی ساختمان آریا پلاک 9-223واحد 8
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8179965545
Phone: +98 31 3650 3146
Mobile: +98 913 109 4043
Fax:
Email: leylarafiei943@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leyle Rafiei
Full name of responsible person - Persian: لیلا رفیعی
Position - English: Nurse Anesthesia
Position - Persian: پرستار بیهوشی
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hezar Jarib
Street address - Persian: هزارجریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8146713543
Phone: +98 31 3620 2020
Mobile: +98 913 109 4043
Fax:
Email: leylarafiei943@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Leyle Rafiei Full name of responsible person - Persian: لیلا رفیعی Position - English: Nurse Anesthesia Position - Persian: پرستار بیهوشی Latest degree: bachelor Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 223-9, unit.8, Aria bilding, West Kargar Alley, Farabi 3 Ave, Sepahan ShahrHezar Jarib Street address - Persian: سپاهان شهر خیابان فارابی3 کوچه کارگر غربی ساختمان آریا پلاک 9-223واحد 8هزارجریب City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81799655458146713543 Phone: +98 31 3650 31463620 2020 Mobile: +98 913 109 4043 Fax: Email: leylarafiei943@gmail.com Web page address:
Protocol summary
Study aim
Comparison of the effect of prophylactic injections of ketamine and Ondansetrone on shivering after cesarean section under spinal anesthesia
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 121 patients. Randomization is done using Random Allocation software.
Settings and conduct
This is a randomized double-blind clinical trial in which the target population of pregnant women is candidates for cesarean section under spinal anesthesia at Beheshti Hospital in Isfahan. Patients are randomly assigned to three groups C, B, and A, and each group is randomly assigned to one of three intervention groups, and the patient's vital signs are monitored before, during, and after surgery. The intervention groups are coded, so the injecting person, the clinical caregiver, and the patient are unaware of the injected intervention and are blind.
Participants/Inclusion and exclusion criteria
Pregnant women in grades I and ASA II, candidates for cesarean section under spinal anesthesia, can be screened if they have no history of high blood pressure, mental illness, heart problems with EF <60%, or kidney problems with GFR <60.
Intervention groups
Intervention group A: 4 mg of Ondansetron,
Intervention Group B; 0.5 mg of ketamine per kilogram of body weight and C intervention group; Normal saline as a placebo is injected into the patient immediately after clamping of the umbilical cord.
Main outcome variables
Shivering
General information
Reason for update
Adress changing
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N20
Registration date:2020-06-10, 1399/03/21
Registration timing:prospective
Last update:2022-07-30, 1401/05/08
Update count:1
Registration date
2020-06-10, 1399/03/21
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
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intravenous injection of Ketamine and Ondansetron in the prevention of the post-operative shivering in Cesarean Section under spinal anesthesia
Public title
Ketamine and Ondansetron in post operative shivering in Cesarean Section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women are candidates for cesarean section
Candidates for Spinal anesthesia
ASA class I and II
The patient's consent to participate in the study
Exclusion criteria:
History of high blood pressure
History of mental illness
History of heart problems with EF <60%
History of kidney problems with GFR <60
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way so that the names of patients enter the randomization software (https://random-allocation-software.software.informer.com/2.0/) if they have the necessary conditions and according to the time of entry. software Randomly assign numbers to each patient, and based on these numbers, patients enter one of the intervention or control groups so that their number reaches the required number in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs and placebo are packaged in the same form with the same volume and coded, and are randomly distributed among patients so
the attending, the clinical caregiver, and the evaluator do not notice the type of medication.
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
2017-06-18, 1396/03/28
Ethics committee reference number
IR.MUI.REC.1396.3.028
Health conditions studied
1
Description of health condition studied
Postoperative shivering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
shivering
Timepoint
Every 15 minutes from the beginning of the operation until the end of recovery
Method of measurement
Using Mahajan and Grassi criteria
2
Description
Central temprature
Timepoint
Every 15 minutes from the beginning of the operation until the end of recovery
Method of measurement
Tympanic thermometer
3
Description
Peripheral Temprature
Timepoint
Every 15 minutes from the beginning of the operation until the end of recovery
Method of measurement
Skin thermometer
Secondary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery
Method of measurement
Non invasive blood pressure measurement
2
Description
Diastolic Blood Pressure
Timepoint
Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery
Method of measurement
Non invasive blood pressure measurement
3
Description
Mean Arterial Blood Pressure
Timepoint
Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery
Method of measurement
Non invasive blood pressure measurement
4
Description
Heart Rate
Timepoint
From the beginning of the spinal anesthesia to the end of recovery
Method of measurement
Heart monitoring device
5
Description
Oxygen saturation
Timepoint
From the beginning of the spinal anesthesia to the end of recovery
Method of measurement
Pulse oximetry device
Intervention groups
1
Description
Intervention group A: Ondansetron is injected into the patient at a dose of 4 mg immediately after umbilical cord clamping.
Category
Treatment - Drugs
2
Description
Intervention Group A; Ketamine 0.5 mg per kilogram of body weight is injected into the patient immediately after clamping the umbilical cord.
Category
Treatment - Drugs
3
Description
Control group C: Normal saline as a placebo is injected into the patient immediately after the umbilical cord clamp.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Behzad Nazemroaya
Street address
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
Maryam Shirini
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?
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
Maryam Shirini
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 4, Melika Bilding, East Aban Alley, Kharazmi 4 Ave, Shahed Blvd, Sepahan shahr Town
City
Isfahan
Province
Isfehan
Postal code
8179969146
Phone
+98 31 3652 0237
Email
m.shirini98@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 of Anesthesia and Intensive Care, Isfahan School of Medicine
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
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
Leyle Rafiei
Position
Nurse Anesthesia
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
leylarafiei943@gmail.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available