Evaluation the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgery in 5Azar hospital in 1402(2023)
Investigating the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgeries.
Design
This clinical trial study has a control group and a control group, a blinded, randomized using block method, phase 3 study on 30 people.
Settings and conduct
The study population is the patients referred to 5 Azar Hospital in Gorgan in 1402 who were hospitalized for orthopedic surgery on the lower limbs.
Blinding of the study, random allocation is one-sided and the anesthesia technician will not know the type of drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 60-18 years
ASA1. 2
Lower limb orthopedic surgery
Normal PT-PTT tests
Exit criteria:Contraindications of spinal anesthesia.
Intervention groups
Immediately after spinal anesthesia, 0.25 mg/kg of ketamine and placebo (normal saline) are injected intravenously according to the study group. The information will be charted every 15 minutes according to the checklist.
Main outcome variables
Nausea and vomiting, sedation caused by ketamine and changes in blood pressure and hear rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231002059586N1
Registration date:2023-10-23, 1402/08/01
Registration timing:prospective
Last update:2023-10-23, 1402/08/01
Update count:0
Registration date
2023-10-23, 1402/08/01
Registrant information
Name
Kazem Kazemnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3115 3367
Email address
kazemnejad@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgery in 5Azar hospital in 1402(2023)
Public title
Evaluation the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgery in 5Azar hospital in 1402(2023)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the study subjects is 18-60 years
ASA1, 2
Orthopedic surgery of the lower limb
PT-PTT tests are normal
The patient must consent to the research.
Exclusion criteria:
Patient dissatisfaction with spinal anesthesia
ASA 3,4,5
Neurological and psychiatric diseases
Myelopathy and peripheral neuropathies
Spinal canal stenosis
Aortic stenosis
Infection
High blood pressure is not controlled
History of cerebral aneurysms
High intracerebral pressure
Pregnancy
MI in the last 3 months
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
people Participating in this study are randomly assigned to two groups of ketamine and placebo. In this way, using a 6-sided dice, the samples are assigned to their groups. A number is written on each side, and each number is assigned to one of the blocks in the table, which shows the desired drug group.
K K P K P 1
P P K P K 2
K K P P K 3
K P P K P 4
P P K P K 5
P K K K P 6
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are not aware of the type of study group and the selection of the patient, each patient's group and the type of medication received will be delivered by one of the researchers related to the patient. The anesthesiology technician in charge of the patient will not know the type of drug in order to reduce the confounding factors, so according to the two groups of injectable drugs, two types of similar syringes that have no specifications will be used and related medication will be prepared by the anesthesia assistant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
5 Azar Hospital, 5 Azar Street
City
gorganodhfhk 5
Province
Golestan
Postal code
4917763681
Approval date
2023-07-25, 1402/05/03
Ethics committee reference number
IR.GOUMS.REC.1402.193
Health conditions studied
1
Description of health condition studied
The effect of ketamine in the prevention of shivering after spinal anesthesia.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering
Timepoint
The occurrence of shivering is checked in 15, 30, 45, 60, 75 minutes after the spinal procedure.
Method of measurement
Based on the patient's clinical symptoms of having or not having shivering, it is done.
Secondary outcomes
1
Description
Hemodynamic changes including: Change in mean arterial pressure
Timepoint
It is measured after spinal anesthesia in 15, 30, 45, 60, 75 minutes.
Method of measurement
mmHg, number per minute, percent
2
Description
nausea and vomiting
Timepoint
The occurrence of nausea and vomiting after spinal anesthesia is checked in 15, 30, 45, 60, 75 minutes.
Method of measurement
It is evaluated based on the occurrence of symptoms of nausea and vomiting.
3
Description
Change in heart rate
Timepoint
It is checked based on the rate of heart rate change after spinal anesthesia in 15, 30, 45, 60, 75 minutes.
Method of measurement
It is measured by the number of heartbeats per minute.
4
Description
Hallucination: Misunderstanding of objects or events that involve human senses. Visual hallucinations are more common in the use of ketamine.
Timepoint
It is checked based on the occurrence of hallucination symptoms after spinal anesthesia in 15, 30, 45, 60, 75 minutes.
Method of measurement
Hallucination is evaluated based on having or not having clinical symptoms.
Intervention groups
1
Description
Intervention group: Ketamine injection
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Azar 5 hospital
Full name of responsible person
Kazem Kazemnejad
Street address
Department of Anesthesia, 5 Azar Hospital, 5 Azar St
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3367
Email
kazemnejad@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Kazem Kazemnejad
Street address
5 Azar Hospital, 5 Azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3367
Email
kazemnejad@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Pparvaneh Ebrahimzadeh
Position
Anesthesia assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5 Azar Hospital,5 Azar Street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3367
Email
dr.parvaneh.ez@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
kazem kazemnejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
5 Azar Hospital, 5 Azar Street
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3367
Email
kazemnejad@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
parvaneh ebrahimzadeh
Position
assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5 Azar Hospital, 5 Azar Street
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3367
Email
dr.parvaneh.ez@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
The reason for this is due to the observance of ethical principles and the observance of the confidentiality of the patient's personal information.
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The data includes specific variables, and in case of side effects, the related data will be shared.
When the data will become available and for how long
Access will start 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The information can be accessed by observing the ethical principles, maintaining the confidential information of the patients and mentioning the name of the study.