Comparison of the effectiveness of Magnesium Sulfate and Ketamine gargle on postoperative sore throat in patient with prone position during Laminectomy surgery.
The effect of Magnesium Sulfate and Ketamine gargle on postoperative sore throat
Design
Patient candidate for Laminectomy surgery randomly and with using table of random number divided in 3 groups and each group contain 20 individuals. Groups; Ketamine group, Magnesium Sulfate group and control's group. Sample size 60 was determined that divided in 3 groups. Clinical trial, single blind, with control group.
Settings and conduct
Patients candidate for Laminectomy surgery in Shohadaye Tajrish hospital divided in groups and participants have no information about groups and receiving medication or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients between 30-70 years old candidate for Laminectomy surgery
Exclusion criteria:
History of Hypertension or cardiac disease
Upper Respiratory Airway Infection
Cleft lip or palate
Arrhythmia
Cardiac conduction disorder
Intervention groups
Three groups; The first group gargles ketamine with 5% Dextrose serum and the second group Magnesium Sulfate plus 5% Dextrose and the third group (control) gargles 5% Dextrose as placebo.
Main outcome variables
The effect of Magnesium Sulfate and Ketamine gargle on postoperative sore throat.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190131042569N2
Registration date:2020-02-14, 1398/11/25
Registration timing:registered_while_recruiting
Last update:2020-02-14, 1398/11/25
Update count:0
Registration date
2020-02-14, 1398/11/25
Registrant information
Name
Nima saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 8939
Email address
nimasaeedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-04-13, 1399/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Magnesium Sulfate and Ketamine gargle on postoperative sore throat in patient with prone position during Laminectomy surgery.
Public title
The effect of Magnesium Sulfate and Ketamine gargle on postoperative sore throat in patient with prone position.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients between 30-70 years old candidate for Laminectomy surgery
Exclusion criteria:
History of Hypertension or cardiac disease
Upper Respiratory Airway Infection
Cleft lip or palate
Arrhythmia
Cardiac conduction disorder
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient who qualify for inclusion after completing the consent form is assigned by the person in charge of this process using a random number table from 1 to 60( 1- 20 Ketamine group, 21-40 Magnesium Sulfate group, 41-60 control group ) where the person is placed on one of the numbers and assigned to one of the 3 specified groups. (Simple randomization by individual using random number table).
Blinding (investigator's opinion)
Single blinded
Blinding description
The anesthesiologist in charge of anesthesia is not aware of the patient's group (intervention or control groups) whom receive anesthesia.
And the person responsible for follow-up and recordings data and pain levels has no information about the intervention or control group and only one person responsible for giving the patient's drug or placebo is aware of the patient groups.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee 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
1985717443
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.599
Health conditions studied
1
Description of health condition studied
Throat pain after intubation
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Post operation throat pain
Timepoint
Upon arrival to recovery, 2,12 and 24 hours after surgery.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Ketamine group: 1 mg/kg ketamine(Rotexmedica company) plus 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction.
Category
Prevention
2
Description
Intervention group2: Magnesium sulfate group: 30 mg/kg Magnesium sulfate(Pasteur Institute) plus 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction.
Category
Prevention
3
Description
Control group: 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Nima Saeedi
Street address
Shohadaye Tajrish Hospital , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziayi
Street address
Third floor, School of Medicine, near the Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar Metri Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi@sbmu.ac.ir
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
Participant data (age, pain severity and type of patient's group) are to be shared.
When the data will become available and for how long
1 year after publication
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Using data and analysis for use in academic research