A comparison between the effectiveness of 2% lidocaine injection into endotracheal tube and the normal method on the incidence of cough and laryngospasm in patients candidating cataract surgery
The goal of this double blind randomized clinical trial was to determine the effect of lidocaine injection into endotracheal tube before extubation in decrease of incidence of cough and laryngospasm compared to normal method. Inclusion criteria: Patients candidating cataract surgery; who were group in class I and II based on the classification of the American Society of Anesthesiology. Exclusion criteria: Chronic obstructive pulmonary disease
The study was performed on patients referred to Valiasr hospital for cataract surgery .
Totally, 96 patients older than 20 years were selected based on Inclusion criteria and randomly divided into two 48 patint groups (control and test groups(.
In test group 100 mg (5ml) of lidocaine 2% and in control group the same volume of placebo (normal saline) was injected into endotracheal tube. The number of coughs and laryngospasm assessed recorded and compared in three periods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406026808N5
Registration date:2014-07-10, 1393/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-10, 1393/04/19
Registrant information
Name
Maryam Tolyat
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 9056
Email address
tolyatm@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2012-12-15, 1391/09/25
Expected recruitment end date
2013-06-15, 1392/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effectiveness of 2% lidocaine injection into endotracheal tube and the normal method on the incidence of cough and laryngospasm in patients candidating cataract surgery
Public title
Effect of lidocaine injection into endotracheal tube on incidence of cough and laryngospasm in patients candidating cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Candidate cataract surgery; class I and II based on the classification of the American Society of Anesthesiology
Exclusion criteria : Chronic obstructive pulmonary disease
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Approval date
2011-02-03, 1389/11/14
Ethics committee reference number
447
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H25.0
ICD-10 code description
Senile incipient cataract
Primary outcomes
1
Description
cough
Timepoint
In two states :after extubation at surgery room and recovery room
Method of measurement
without cough, moderate cough, including one to five coughs and severe cough, including more than five cough
Secondary outcomes
1
Description
laryngospasm
Timepoint
In two states:after extubation at surgery room and recovery room
Method of measurement
The presence of laryngospasm
Intervention groups
1
Description
In test group: 100 mg (5ml) of lidocaine 2% was injected into endotracheal tube
Category
Treatment - Drugs
2
Description
In control group (5ml) same volume of placebo (normal saline) was injected into endotracheal tube
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zangoue
Street address
Birjand University of Medical Sciences, Ghafarie Street, Birjand, Jonoubi khorasan, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
Msc
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafarie Street, Birjand,Jonoubi khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 1882 5450
Fax
Email
tolyatm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Malihe Zangoue
Position
Proficient in Anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 1442 2536
Fax
Email
mzangoue@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
Msc
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)