The aim of this study was to evaluate the effect of adding dexamethasone to intracuff lidocaine 2% on the respiratory complications after general anesthesia in a randomized, double blind, prospective clinical trial. 208 patients were enrolled and assigned into four group to fill tracheal tube cuff with air, lidocaine 2%, dexamethasone, or Lidocaine2%+dexamethasone. After restoring breathing and tracheal extubation, cough, bucking, and laryngospasm were recorded till one hour and 24 hours later and pharyngeal pain was assessed 24 hours later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711111617N1
Registration date:2010-06-14, 1389/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-06-11, 1388/03/21
Expected recruitment end date
2009-12-11, 1388/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding dexamethasone to intracuff lidocaine 2% on decreasing the respiratory complications after general anesthesia
Public title
The effect of adding dexamethasone to intracuff lidocaine 2% on decreasing the respiratory complications after general anesthesia: a randomized, double blind, clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I-II, candidate for elective surgery under general anesthesia with tracheal intubation
Exclusion criteria: head and neck surgery, respiratory tract infection, asthma, nasogastric tube, increase intracranial or intraoccular pressure, denial of patients
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
208
Randomization (investigator's opinion)
N/A
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
Ethic committee of Kermanshah University of Medical Sciences
Street address
Pro-Vice-Chancellor for Research, Kermanshah University of Medical Sciences,
City
Kermanshah
Postal code
Approval date
2009-05-11, 1388/02/21
Ethics committee reference number
74201346
Health conditions studied
1
Description of health condition studied
cough
ICD-10 code
A37.9
ICD-10 code description
Whooping cough, unspecified
Primary outcomes
1
Description
cough
Timepoint
At the baseline and one hour and 24 hours later
Method of measurement
observation
2
Description
bucking
Timepoint
At the baseline and one hour and 24 hours later
Method of measurement
observation
3
Description
laryngospasm
Timepoint
At the baseline and one hour and 24 hours later
Method of measurement
observation
Secondary outcomes
1
Description
pharyngeal pain
Timepoint
At the baseline and again 24 hours later
Method of measurement
visual analogue scale
Intervention groups
1
Description
control group: air, Intracuff until there was no air leak at 25 CmH2o airway pressure
Category
Treatment - Drugs
2
Description
Lidocaine 2%, Intracuff until there was no air leak at 25 CmH2o airway pressure
Category
Treatment - Drugs
3
Description
Lidocaine2%+dexamethasone, Intracuff until there was no air leak at 25 CmH2o airway pressure
Category
Treatment - Drugs
4
Description
Dexamethasone, Intracuff until there was no air leak at 25 CmH2o airway pressure
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Habiballah Khazaie
Street address
Deputy of Research, Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Samad Nourizad
Street address
Kermanshah University of Medical Sciences and health Services
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Imam Reza Hospital
Full name of responsible person
Zahra Johari
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Departement of Anesthesia and intensive care, Imam Reza Hospital,
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
mchoobsaz@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
mchoobsaz@kums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)