Investigation of the effect of licophar tablet on reduction of the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Investigation of the effect of licophar tablet on reduction of the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Design
clinical trial with control and parallel groups, single blind, randomized.
Settings and conduct
This study will be conducted in Khatam Eye Hospital in Mashhad on 160 patients undergoing cataract surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients undergoing cataract surgery with operating time of less than 60 minutes. Exclusion criteria: use of NSAIDS in the past 2 days, use of drugs and cigarettes, upper airway problem (obesity, patients with ASA above 2, swollen tonsils), asthma, pharyngitis, neuromuscular problems (such as Myasthenia gravis – ALS), mental health problems in a way that the, intended outcome cannot be evaluated in the patient, excessive obesity (BMI > 35), diabetes, hypertension, being in pregnancy or lactation.
Intervention groups
Intervention group: Licophar Lozenge (produced by Goldaru company) will be given to patients half an hour before surgery.
Control group: No drug will be used.
Main outcome variables
Rate of sore throat based on visual analog scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170415033428N4
Registration date:2020-03-15, 1398/12/25
Registration timing:registered_while_recruiting
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
Elham Bakhtiari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 3943
Email address
bakhtiarie@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-17, 1398/11/28
Expected recruitment end date
2020-07-18, 1399/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of licophar tablet on reduction of the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Public title
Investigation of the effect of licophar tablet on sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing cataract surgery with operating time of less than 60 minutes
Exclusion criteria:
use of NSAIDS in the past 2 days
use of drugs and cigarettes
upper airway problem (obesity, patients with ASA above 2, swollen tonsils)
asthma
pharyngitis
neuromuscular problems (such as Myasthenia gravis – ALS)
mental health problems in a way that the intended outcome cannot be evaluated in the patient
excessive obesity (BMI > 35)
diabetes, hypertension, being in pregnancy or lactation
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be carried out using table of rnadom numbers available at 'www.randomization.com' website where the prodiced numbers are placed in sealed envelopes assigning each patient to one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator and analyst will be unaware of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.707
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H59.0
ICD-10 code description
Disorders of the eye following cataract surgery
Primary outcomes
1
Description
rate of sore throat
Timepoint
at 3,6,12 and 24 hours after operation
Method of measurement
based on visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Licophar Lozenge (produced by Goldaru company) will be given to patients half an hour before surgery.
Category
Treatment - Drugs
2
Description
Control group: No drug will be used.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam eye hospital
Full name of responsible person
Mohammad Alipour
Street address
Khatam eye hospital, Gharani 31, Gharani Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٩١٩١
Phone
+98 51 3728 1401
Email
Alipourm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?