The effect of diphenhydramin hydrochloride gargling in the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Determining the effect of diphenhydramin hydrochloride gargling in the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Design
Clinical trials with control group, phase 2, with parallel groups, blinding were performed on 83 patients.
Settings and conduct
This project is being done at Khatam Ophthalmology Hospital and in patients undergoing cataract surgery.
Participants/Inclusion and exclusion criteria
Patients undergoing cataract surgery with surgery less than 60 minutes
Intervention groups
Before using laryngeal mask in control group, gargle method was used with 20 cc normal saline . The intervention group used 8 mg diphenhydramine equivalent to 20 mg in 12 cc normal saline.
Main outcome variables
Age, sex, group therapy, degree of sore throat, intensity of sore throat, size of laryngeal mask, duration of operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N9
Registration date:2018-10-01, 1397/07/09
Registration timing:registered_while_recruiting
Last update:2018-10-01, 1397/07/09
Update count:0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-02-26, 1392/12/07
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diphenhydramin hydrochloride gargling in the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Public title
The effect of diphenhydramin hydrochloride gargling in the sore throat of patients undergoing cataract surgery after insertion of laryngeal mask airway
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cataract surgery with surgery less than 60 minutes
Age over 15 years
Exclusion criteria:
Surgery for more than two hours
Consumption of NSAIDs in the last two days
Consumption of smoking and Opiate
Sensitization
Laryngeal mask insertion problem
Diseases such as asthma and pharyngitis
Obesity too
Muscular neuromuscular problems
Mental problems
Age
From 15 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
83
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person who injects the drug do not aware of the type of drug
Placebo
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
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2014-02-26, 1392/12/07
Ethics committee reference number
911228
Health conditions studied
1
Description of health condition studied
cataract surgery
ICD-10 code
H59.0
ICD-10 code description
Keratopathy (bullous aphakic) following cataract surgery
Primary outcomes
1
Description
Severe sore throat
Timepoint
after surgery
Method of measurement
interview
2
Description
Pain of Sore throat
Timepoint
after surgery
Method of measurement
VAS Scale
Secondary outcomes
1
Description
Laryngeal Mask Size
Timepoint
before surgery
Method of measurement
standard number
Intervention groups
1
Description
Intervention group: Diphen Hydramine 8cc Cylinder Spool 20 mg in 12 cc normal saline before applying mask
Category
Prevention
2
Description
Control group: Gargle with 20 cc normal saline before applying mask
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mohsen Saber Mmoghaddam
Street address
Department of Anesthesiology, Ghaem Hospital, Square Taghiabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
SaberMoghaddamM@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
International Offic Administration Center(Qoreishi Building) ; Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
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?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghaddam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
sabermoghadamm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghaddam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Taghiabad Square
City
Mashad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518525209
Email
sabermoghadamm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghaddam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
sabermoghadamm@mums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data file
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Statistical analyzes are permitted in overview articles on delivered data
From where data/document is obtainable
Send an email to sabermoghaddamm@mums.ac.ir
What processes are involved for a request to access data/document