The aim of this study is to compare the effectiveness of low dose Ketamine and Propofol in Prevention of Shivering in Patients during Cesarean Section under Spinal Anesthesia
Design
Clinical trial with control group with parallel groups, Triple blind, randomized, and sample size is 132.
Settings and conduct
In this study 132 patient with elective Cesarean section with spinal anesthesia were included and will be divided into three groups of 44. All patients with marcaine 0.5% undergo spinal anesthesia.The Ketamine group will receive 10 mg of ketamine, Propofol group, 10 mg of propofol and 2 ml of Normal saline in placebo group immediately after embryo withdrawal.For blindness the volume of injectable solution will be 2 cc in each of three groups.The preparing of drugs is done by an anesthetic technician who is not involved in this study and for injection is given to someone who is unaware of contents of the syringes.A person who is unaware of the type of injectable drug evaluate the shivering of patients during and 0.5 h after operation in recovery room and records the results.Nausea and vomiting of patients are also recorded in these times.The date analysis in this study is done by person who in unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria are pregnant women aged 15_45 years old; patients with ASA class I & II; patients signed informed consent and exclusion criteria are history of allergy to Ketamine and Propofol; placenta previa; preeclampsia & eclampsia; Raynaud's syndrome; thyroid diseases and cardiovascular diseases.
Intervention groups
The ketamine group will receive 10 mg of ketamine, Propofol group, 10 mg of propofol and 2 ml of normal saline in placebo group immediately after embryo withdrawal. The injectable solution will be equal to 2 cc in each of the three groups.
Main outcome variables
Shivering in patients during cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180930041181N1
Registration date:2018-10-22, 1397/07/30
Registration timing:prospective
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
Faezeh Javidnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3643 1031
Email address
f.javidnia@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of low dose Ketamine and Propofol in prevention of Shivering in Patients during Sesarean section under Spinal Anesthesia
Public title
Effect of Ketamine & Propofol in prevention of Shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant Women aged 15_45 years old
Patients signed informed consent
Patients with ASA class I & II
Exclusion criteria:
History of previous allergy to Ketamine & Propofol
Placenta Previa
Preeclampsia and eclampsia
Raynaud's Syndrom
Thyroid disease
Cardiovascular disease
Psychological Problems
Body temperature < 36 or > 38
Parturients with ASA class III or high
Age
From 15 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:
132
Randomization (investigator's opinion)
Randomized
Randomization description
A Convenient Sampling method will be used to enter the patients.These patients will be randomly assigned into three groups: Ketamine, Propofol and Placebo.The randomization tool will be Opaque envelopes in this study.For randomization three type of envelopes to the number of sample size is provided, an envelope randomly selected from the envelopes and based on the type of envelope code selected (type A, B and C )the prescribed drug for each code will be injected to patients.Preparing of these three drugs is done by an anesthetic technician who is not involved in this study and for injection is given to someone who is unaware of contents of the syringes.In the Ketamine group, 10 mg of ketamine and in the Propofol group, 10 mg of Propofol and 2 ml of Normal Saline will be injected in the Placebo group.For blindness the volume of injectable solution will be 2 cc in each of three groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Preparing of these three drugs is done by an anesthetic technician who is not involved in this study and for injection is given to someone who is unaware of contents of the syringes.In the Ketamine group, 10 mg of ketamine and in the Propofol group, 10 mg of Propofol and 2 ml of Normal Saline will be injected in the Placebo group.For blindness the volume of injectable solution will be 2 cc in each of three groups.A person who in not aware of the type of injectable drug evaluate patients during and after surgery. The data analyst in this study will also be unaware of the type of drug used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences
City
Ardebil
Province
Ardabil
Postal code
۸۵۹۹۱۵۶۱۸۹
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.ARUMS.REC.1396.203
Health conditions studied
1
Description of health condition studied
Postoperative Shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Shivering
Timepoint
During and after surgery
Method of measurement
Shivering score (0_4)
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
During and after surgery
Method of measurement
Nausea and vomiting Score (1_4)
Intervention groups
1
Description
Intervention group: 10 mg Ketamine immediately after embryo out
Category
Treatment - Drugs
2
Description
Intervention group: 10 mg Propofol immediately after embryo out
Category
Treatment - Drugs
3
Description
Control group: 2 cc Normal Saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Faezeh Javidnia
Street address
Alavi hospital., Shahid Moadi Avenue
City
Ardebil
Province
Ardabil
Postal code
5815913536
Phone
+98 44 3643 1031
Email
f.javidnia@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahab Bohlooli
Street address
Daneshgah Ave., Ardebil University of Medical siences
City
Ardebil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3352 2391
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Khatereh Isazadehfar
Position
Community Medicine Specialist/Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Daneshgah Ave., Ardebil University of Medical siences
City
Ardebil
Province
Ardabil
Postal code
۸۵۹۹۱۵۶۱۸۹
Phone
+98 45 3352 2247
Email
kh.isazadehfar@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Ahmad Ghazi
Position
Anesthesiologist/Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah Ave., Ardebil University of Medical siences
City
Ardebil
Province
Ardabil
Postal code
۸۵۹۹۱۵۶۱۸۹
Phone
+98 44 3352 2247
Email
a.ghazi@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Faezeh Javidnia
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 20, Pardis Alley 1., Parvin E'tesami Ave., Valiasr Town
City
Khoy
Province
West Azarbaijan
Postal code
۵۸۱۵۹۱۳۵۳۶
Phone
+98 44 3643 1031
Email
f.javidnia@arums.ac.ir
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