Determination of the prophylactic effect of ketamine and dexmedotomedine on shivering of patients undergoing inguinal hernia by spinal anesthesia
Design
It will be a non-randomized clinical trial in Phase 3. Blinding will not be performed. Patients will be selected in three groups of 50 at Fatemi Hospital of Ardabil.
Settings and conduct
Shivering severity will be determined using BSAS 23 trained by anesthesia technician. During surgery, patients' hemodynamic symptoms will be charted. Shivering will be registered in 4 steps: The moment the patient entering to recovery room, 15 minutes later, 30 minutes later, 45 minutes later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate herniorrhaphy with spinal anesthesia, consent for inclusion, 18-65 years old
Exclusion criteria: history of drug sensitivity, history of peptic ulcer, systemic infection or immunodeficiency, history of use of monoamine oxidase inhibitor drugs, untreated hypothyroidism, benign prostatic hypertrophy, urinary stenosis and congenital hemorrhagic diseases.
Intervention groups
Samples will be divided into three groups, dexmedetomidine and ketamine and the control groups. The first group (ketamine recipients): 50 patients receiving 0.3 mg / kg of diluted ketamine in normal saline with a total volume of 5 ml syringe (injected immediately after spinal anesthesia), dexmedetomidine group: 50 patients containing 1 μg For each kg of body weight diluted dexmedetomidine in normal saline with a total volume of 5 ml syringe (injected immediately after spinal anesthesia). Control group will receive only normal saline. These 3 syringes will be identical in color (the content of all 3 syringes is colorless) and volume (all 3 syringes contain 5 ml of liquid).
Main outcome variables
Shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190930044937N1
Registration date:2019-10-20, 1398/07/28
Registration timing:registered_while_recruiting
Last update:2019-10-20, 1398/07/28
Update count:0
Registration date
2019-10-20, 1398/07/28
Registrant information
Name
Vahid Adiban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
p.poshtareh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Prophylactic effect of ketamine and dexmedetomidine on shivering in patients undergoing inguinal hernia surgery under spinal anesthesia.
Public title
Preventive role of ketamine and dexmedetomidine on control of shivering in patients undergoing hernia surgery by spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for inguinal hernias.
No life-threatening illness
Exclusion criteria:
Weight over 100 kg
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
No. 1, Moallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Approval date
2019-07-22, 1398/04/31
Ethics committee reference number
IR.ARUMS.REC.1398.182
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering
Timepoint
After surgery at the beginning of recovery, 15 minutes, 30 minutes and 45 minutes
Method of measurement
BSAS 23 measured by trained anesthesia technician.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ketamine recipients consisting of 50 patients receiving 0.3 mg / kg of diluted ketamine in normal saline with total syringe volume of 5 ml (injected immediately after spinal anesthesia).
Category
Treatment - Drugs
2
Description
Intervention group 2: Dexmedetomidine group: 50 patients will receive 1mg / kg of diluted dexmedetomidine in normal saline with total volume of 5 ml syringe (injection immediately after spinal anesthesia).
Category
Treatment - Drugs
3
Description
Control group: 50 patients will receive normal saline only. These 3 syringes will be identical in color (the content of all 3 syringes is colorless) and volume (all 3 syringes contain 5 ml of liquid).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Pedram Poshtareh
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843778
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh Naftchi
Street address
No. 1, Moallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
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
Vahid Adiban
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Emamkhomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843777
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vahid Adiban
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Emamkhomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843777
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vahid Adiban
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Emamkhomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843777
Phone
+98 45 3323 0739
Email
meisamfooladi@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
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The questionnaires will be made available anonymously and with a file number.
When the data will become available and for how long
After completing the study
To whom data/document is available
University professors
Under which criteria data/document could be used
In order to find out how to work in SPSS file, anonymous questionnaires will only be available with file number.
From where data/document is obtainable
Contact Dr. Vahid Adiban.
What processes are involved for a request to access data/document
Information is available after contacting Dr. Vahid Adiban and University approval