The effect of ketamine and magnesium sulfate gargle on postoperative sore throat
Design
Patients who are candidates for Laminectomy surgery are randomly divided into three groups using a table of random numbers and each group consists of 20 people. Groups: ketamine group, magnesium sulfate group, and control group. The sample size was determined to be 60 and divided into 3 groups. a two-blind clinical trial with a control group
Settings and conduct
Patients who are candidates for Laminectomy surgery at Shohada Tajrish Hospital are divided into three groups, and participants do not have information about the groups and receiving medication or placebo
Participants/Inclusion and exclusion criteria
All patients between 25 and 75 years old are candidates for Laminectomy surgery
Exclude criteria: History of high blood pressure or heart disease and upper respiratory tract infection
Intervention groups
Three groups: The first group gargles ketamine with 5% dextrose serum
The second group gargles with magnesium sulfate with 5% dextrose and the third group (control) gargles as a placebo.
Main outcome variables
Postoperative sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050379N1
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Hamidreza Azizifarsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
h.faresani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ketamine and magnesium sulfate gargle on postoperative sore throat in patient under laminectomy
Public title
The effect of Ketamine and magnesium sulfate gargle on postoperative sore throat in patient under laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients (25-75 old) with ASA class 1,2( American Society of Anesthesiology)
simple intubation
single randomized, individual, computerized random number table
we introduce a number for each patient, and then by assay computerized random, number table, the patients will be divided in 3 experimental groups. this randomization will be done by a principal investigator, and the nurse, the physician, and the person who does the analytical evaluation will be blind related to this randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Anesthetist responsible for delivering anesthesia will not be informed about the patients group. the person who will record the data,will be blind to the groups
Placebo
Used
Assignment
Parallel
Other design features
NO
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science,Arabi Ave, Daneshjoo Blvd, Velenjak,Tehran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.349
Health conditions studied
1
Description of health condition studied
Pain in throat
ICD-10 code
pain in th
ICD-10 code description
R07.0
Primary outcomes
1
Description
Sore throat after surgery
Timepoint
Upon entering recovery, 2, 12 and 24 hours after surgery
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: 1 mg per kg body weight of ketamine (Rotex Medica Company) with 30 cc of 5% dextrose serum is gargled by the patient for 30 seconds 15 minutes before the start of anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group 2: Magnesium sulfate group: 30 mg per kg body weight of 20% magnesium sulfate (Pasteur Institute) with 30 cc of 5% dextrose, 15 minutes before the start of anesthesia, the patient gargles for 30 seconds.
Category
Treatment - Drugs
3
Description
Control group: 30 cc of 5% dextrose serum is gargled by the patient for 30 seconds 15 minutes before the start of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
shohada tajrish hospital
Full name of responsible person
dr. Mehrdad Feizi
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Valiasr St., corner of Niayesh, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 8820 0119
Email
h.faresani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seied Ali Ziayi
Street address
Third floor, school of Medicine,near Taleghani Hospital,Evin,Shahid Chamran High way
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Fax
+98 21 2274 1174
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Department of Shahid Beheshti University of medical science
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Azizi Faresani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tajrish Squre
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
h.faresani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shayesteh Khorasanizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tajrish Squre
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
h.faresani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Azizi Faresani
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
pharmacy faculty of Shahid Beheshti university of medical sciences
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 8820 0119
Email
zahra.azizi97@yahoo.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
Data and documentation after being unidentified are also published as the main consequence
When the data will become available and for how long
7/11/2021
To whom data/document is available
Paramedical medical students, anesthesia residents
Under which criteria data/document could be used
for research and cite it
From where data/document is obtainable
h.faresani@gmail.com
What processes are involved for a request to access data/document
It will be delivered within 10 days by sending an email