Determining the effect of different doses of ketamine on pain control after cesarean section in patients under spinal anesthesia
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 120 patients. Random allocation software was used for randomization.
Settings and conduct
The study will be conducted in Hajar Hospital, and the participants and the statistical consultant will not know which of the study groups the participants are in. After spinal anesthesia, the intervention groups will receive the bolus dose of ketamine immediately after the umbilical cord clamp and the infusion dose until the end of the procedure. The baby's Apgar score will be recorded at 1 and 5 minutes after birth. After cesarean section, the researcher will record the time of the first feeling of pain using Analogue Scale Visual. The time required for pain medication after the completion of spinal anesthesia and the complications will also be recorded.
Participants/Inclusion and exclusion criteria
Conditions for entering the study
1. Having a term pregnancy and ASA class I, II
2. Absence of any underlying diseases
3. Absence of any mental illnesses or mental disorders
Conditions for withdrawing from the study
1. Having one of the diseases associated with pregnancy, such as gestational blood pressure or gestational diabetes and fetal problems
2. Allergy to ketamine or similar drugs
3. BMI higher than 30
Intervention groups
The first intervention group will receive 0.25 mg/kg bolus and 0.125 mg/kg continuous infusion during surgery of ketamine. The second intervention group will receive 0.5 mg/kg bolus and then 0.25 mg/kg continuous infusion of ketamine. The control group will also receive normal saline equal to the volume of liquid injected in the intervention groups.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230417057937N1
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
amin rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3452 3824
Email address
st-rabiei.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Different Doses and side effects of Ketamin for Pain Control after Cesarean Section Surgery in Patients with Spinal Anesthesia
Public title
Investigating the effect of ketamine in pain control after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a term pregnancy and ASA(American Society of Anesthesiologists) class I, II
Participants in the study should refer electively for caesarean section
Consent to participate in the study
Absence of any underlying diseases
Absence of any mental illnesses or mental disorders
Exclusion criteria:
The presence of one of the diseases associated with pregnancy, such as gestational blood pressure or gestational diabetes and fetal problems.
Allergy to ketamine or similar drugs
BMI above 30
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants to 3 groups will be done by permutation blocks with a size of 40. The Random Allocation software will prepare the randomization list and will be given to a person who does not know the content of the groups' interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to make the study double-blind, the patients will be selected by a person who has no role in examining the patient based on the list of random numbers and the file number will be selected as codes 1, 2, and 3, and the drug and placebo will be injected by the researcher, and the patient will be examined before and It is also performed by the researcher after cesarean section. The patient does not know what group he is in, and the statistical consultant will only know about the studied groups in the form of codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733424
Approval date
2022-06-08, 1401/03/18
Ethics committee reference number
IR.SKUMS.MED.REC.1401.009
Health conditions studied
1
Description of health condition studied
Post-surgery pain
ICD-10 code
O74.8
ICD-10 code description
Other complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Comparison of postoperative pain scores in patients receiving intravenous ketamine and the group receiving normal saline
Timepoint
0, 30, 60, 90, 120 minutes and 4, 6, 12, 24 hours after cesarean سثزفهخد
Method of measurement
Analogue Scale Visual
Secondary outcomes
1
Description
Determining the relative frequency of hallucinations in the group receiving intravenous ketamine
Timepoint
20 minutes after receiving the first dose of medicine
Method of measurement
Based on questions from the patient
2
Description
The time required for pain medication after the completion of spinal anesthesia
Timepoint
The first 24 hours after cesarean section
Method of measurement
Time of drug administration
3
Description
Apgar score of the newborn
Timepoint
The first and fifth minutes after birth
Method of measurement
It includes 5 components: heart rate, respiratory effort, muscle tone, reflex excitability, color
Intervention groups
1
Description
The first intervention group: Ketamine is initially given as a bolus dose of 0.25 mg/kg and then as a continuous infusion of 0.125 mg/kg during the operation.
Category
Treatment - Drugs
2
Description
The second intervention group: Ketamine is initially given as a bolus dose of 0.5 mg/kg and then as a continuous infusion of 0.25 mg/kg during the operation.
Category
Treatment - Drugs
3
Description
Control group: they will receive normal saline injection equal to the volume of liquid injected in the intervention groups.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Azadeh Bahadori
Street address
Hajar hospital, Parastar St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 5505
Email
Hajar-Hospital@SKUMS.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeisi
Street address
Vice Chancellory for Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 9509
Email
elhamraeisi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Amin Rabiei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashani dormitory, Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733424
Phone
+98 38 3452 3824
Fax
Email
aminrabiei1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Amin Rabiei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashani dormitory, Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733424
Phone
+98 38 3452 3824
Fax
Email
aminrabiei1997@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Amin Rabiei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashani dormitory, Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733424
Phone
+98 38 3452 3824
Fax
Email
aminrabiei1997@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutes
Under which criteria data/document could be used
to be used in future studies
From where data/document is obtainable
amin rabiei
aminrabiei1997@gmail.com
What processes are involved for a request to access data/document
Presenting documents of working in academic and scientific institutions