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Comparison the incidence of sore throat after laryngeal mask insertion in patients undergoing cataract surgery in four different groups

Protocol summary

Summary
Purpose: Evaluation and comparison of the effects of three different methods for reducing postoperative sore throat with the control group. Design and criteria: This study is prospective and clinical trial. The research is done on 240 patients with ASA I, II who were candidates of cataract surgery under general anesthesia with laryngeal mask airway insertion and are not addict or mental retard. They are divided to four groups, each with 60 people randomly. Methods and interventions: No supplementary method is used in the control group. In the second and third groups, cuff is rinsed with lidocaein gel and saline before laryngeal mask airway insertion respectively. In the fourth group mouth is washed before laryngeal mask airway removal. Primary outcome: Prevalence of sore throat is measured during the recovery and before discharging the patients (3-4 h after the operation) using verbal analogue scale system.

General information

Acronym
postoperative sore throat
IRCT registration information
IRCT registration number: IRCT201203079229N1
Registration date: 2013-05-10, 1392/02/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Mehryar Taghavi Gilani
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
taghavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of Medical Science (MUMS)
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-05-20, 1392/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the incidence of sore throat after laryngeal mask insertion in patients undergoing cataract surgery in four different groups
Public title
decreasing of postoperative sore throat
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: cataract surgery; ASA I-II exclusion criteria: addiction; mental retard; laryngeal mask airway insertion problems; tracheal intubation
Age
From 20 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical University of Mashhad
Street address
Ghoreishi apartment, Daneshgah str
City
Mashhad
Postal code
Approval date
2012-11-05, 1391/08/15
Ethics committee reference number
900825

Health conditions studied

1

Description of health condition studied
sore throat after laryngeal mask airway
ICD-10 code
j39/9
ICD-10 code description
Disease of upper respiratory tract, unspecified

2

Description of health condition studied
postoperative sore throat
ICD-10 code
J95.8
ICD-10 code description
Other postprocedural respiratory disorders

Primary outcomes

1

Description
sore throat after layngeal mask airway insertion
Timepoint
recovery and discharge time
Method of measurement
verbal analogue scale

Secondary outcomes

1

Description
sore throat
Timepoint
recovery and discharge time
Method of measurement
verbal analogue scale

Intervention groups

1

Description
control group: no emolient and technique don,t use before laryngeal mask airway insertion
Category
Treatment - Other

2

Description
lidocaine group: lidocaine gel use on cuff before laryngeal mask airway insertion
Category
Treatment - Drugs

3

Description
saline group: rinsing of cuff with saline before laryngeal mask airway insertion
Category
Treatment - Drugs

4

Description
mouth washimg group: washing of mouth with 20 ml saline before laryngeal mask airway removal
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbiaa Hospital
Full name of responsible person
Mehryar Taghavi Gilani
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medical University of Mashhad
Full name of responsible person
Mehryar Taghavi Gilani
Street address
Khatam Al-Anbiaa Hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical University of Mashhad
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Medical University of Mashhad
Full name of responsible person
Mehryar Taghavi Gilani
Street address
Khatam Al-Anbiaa Hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical University of Mashhad
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Medical University of Mashhad
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Khatam Al-Anbiaa Hospital
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
taghavim@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical University of Mashhad
Full name of responsible person
Mehryar Taghavi Gilani
Position
MD/ Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Khatam Al-Anbiaa Hospital
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
taghavim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical University of Mashhad
Full name of responsible person
Mehryar Taghavi Gilani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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