Comparison of the effects of Dexmedmoedine, Peptidine and Ketamine on shivering during operation in spinal anesthesia
Design
Clinical trial with control group, with parallel groups, double blinded.
Settings and conduct
The medications were previously prepared by an anesthetist in 10cc syringes labeled A, B, C, D and injected by anesthesiologist by an infusion pump in about 10 minutes. Then the patient was placed in a sitting position, and the space between the vertebrae Either L3-L4 or L4-L5 was injected with quinck needle 25 in Median 2 cc bupivacaine 0.5% Hyperbaric in subarakivide space. The patient was then placed in a sleep state and oxygen was given to the patient at 2 liters per minute. The ambient temperature was 23 ° C. After the block was stabilized, a T8-T10 surgical operation started.
Participants/Inclusion and exclusion criteria
Patients aged 18-45 years with ASA class, one and two candidates for elective orthopedic surgery under spinal anesthesia in the operating room of Shahid Mohammadi Bandar Abbas hospital in 1396-1396.
Intervention groups
The first group received ketamine 0.5 mg/kg, and the second group received pethidine 0.5 mg/kg and the third group received dimethomidine 0.5 microgram/kg and the control group received normal intravenous 5 min before subaracneid block.
Main outcome variables
Degree of shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170101031697N3
Registration date:2019-07-27, 1398/05/05
Registration timing:retrospective
Last update:2019-07-27, 1398/05/05
Update count:0
Registration date
2019-07-27, 1398/05/05
Registrant information
Name
Afshin Parvizpanah
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 6625
Email address
afshin.parvizpanah@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2016-03-21, 1395/01/02
Actual recruitment end date
2018-02-09, 1396/11/20
Trial completion date
2018-02-21, 1396/12/02
Scientific title
Comparison the effect of Dexmedetomidine and Ketamin and Pethidine on prevention of shivering during spinal anesthesia
Public title
Comparision the effect of Dexmedetomidine and Ketamin and Pethidin on prevention of shivering during spinal anaesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade one and two who were candidates for elective orthopedic surgery under spinal anesthesia.
Exclusion criteria:
Those who do not agree to prescribe spinal anesthesia.
Provisions for the prescription of spinal anesthesia are prohibited.
Patients who are allergic to medications in the study.
The patient should be in urgent cases.
Patients who have drug addiction.
Patients who fail in the nerve block.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the patients, patients were randomly assigned to the study groups. Randomization was carried out in a sub-unit using statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The pump syringes were prepared by an expert in the anesthetic room and the assistant did not know its content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Anesthesiology Research Center, Shahid Mohammadi Hospital, Islamic Republic Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
HUMS.REC.1395.006
Health conditions studied
1
Description of health condition studied
Effect of Ketamine and Pethidine and Dexmedmotidine on preventing chills during surgery during spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intraoperative shivering during spinal anesthesia
Timepoint
Every 5 minutes to 20 minutes, and then every 10 minutes to 70 minutes, shivering was recorded by an anesthetic expert in a patient's questionnaire.
Method of measurement
According to Clinical Obstetrician Anesthesiologist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ketamine 0.5 mg/kg
Category
Treatment - Drugs
2
Description
Intervention group: Pethidine 0.5 mg/kg
Category
Treatment - Drugs
3
Description
Intervention group: Dexmedetomidine 0.5 micrograms per kilogram
Category
Treatment - Drugs
4
Description
Control group: Normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi hospital, Bandar Abbas;IRAN
Full name of responsible person
Said Kashani
Street address
Islamic Republic Of Blvd , Shahid Mohammadi Hospital , Bandar Abbas Town , Research Center , Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Street address
Islamic Republic Blvd , Center for Research Vice , Shahid Mohammadi Hospital , Bandar Abbas Town ,Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd , Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd , Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd , Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@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
No - There is not 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
SPSS file
When the data will become available and for how long
5/17/2019
To whom data/document is available
Researchers and referees
Under which criteria data/document could be used
Obtaining a written permit and mentioning the name in the sources
From where data/document is obtainable
Dr. Saeed Kashani Sdkashani486@gmail.com
What processes are involved for a request to access data/document