In this study we compare the incidence and severity of sore throat after interateracheal intubation by Macintosh laryngoscope to Glidescope in 300 patients who have the following conditions under General anesthesia.
Inclusion criteria: Adult patients aged between 15 and 60 yr;A.S.A physical status 1 or 2 ; All patients underwent a preoperative air way evaluation they had early air way ;Patients who were operated in the supine position ;The incidence of Intubation In the End of Surgery is low;Time of Surgery: 2-4 hour. Exclusion criteria:Patients who had clinical evidence of active pulmonary disease;Patients had the previous intubation(If presence previous Anatomical Injury);Patients had artificial denture;Patients had congenital and acquisitive deformity in face neck and mouth and air way;Patients scheduled for neck or thoracic surgery;There were pathological wastage in mouth and pharynx
Patients divided to two groups by random table numbers. One group intubated by Macintosh laryngoscope and the other group by Glidescope. Intubation Performed by tube number 7 or 7.5. Cuff tube adjusted between 20-25 mmHg. General anesthesia induced and maintained in a similar protocol. Patients extubation Performed deeply. After operation patients for sore throat questioned and interviewed in times: 1, 6, 24 and 48 hours by a 3 steps scale (contained none, moderate and high).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309193773N9
Registration date:2014-01-31, 1392/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
]ncidence of sore throat after tracheal intubation
Public title
Comparison of incidence of sore throat after tracheal intubation by Macintosh laryngoscope and Glidescope
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Adult patients aged between 15 and 60 yr;A.S.A physical status 1 or 2 ; All patients underwent a preoperative air way evaluation they had early air way ;Patients who were operated in the supine position ;The incidence of Intubation In the End of Surgery is low;Time of Surgery: 2-4 hours. Exclusion criteria:Patients who had clinical evidence of active pulmonary disease;Patients had the previous intubation(If presence previous Anatomical Injury);Patients had artificial denture;Patients had congenital and acquisitive deformity in face neck and mouth and air way;Patients scheduled for neck or thoracic surgery;There were pathological wastage in mouth and pharynx
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
Keshavarz Blv. Cross Ghods
City
Tehran
Postal code
Approval date
2011-10-31, 1390/08/09
Ethics committee reference number
15468.210.د.90
Health conditions studied
1
Description of health condition studied
Dysphonia
ICD-10 code
R49.0
ICD-10 code description
Dysphonia,Hoarseness
2
Description of health condition studied
sore throat
ICD-10 code
J39.1
ICD-10 code description
acute sore throat,pharyngeal
Primary outcomes
1
Description
Incidence of sore throat
Timepoint
1,6,24,48 hours after operation
Method of measurement
By interview and by a 3 step scale ( contained none, moderate and high)
2
Description
Intensity of sore throat
Timepoint
1,6,24,48 hours after operation
Method of measurement
By interview and by a 3 step scale ( contained none, moderate and high)
Secondary outcomes
1
Description
Incidence of hoarseness following intubation
Timepoint
1,6,24,48 hours after ooperation
Method of measurement
By interview and by a 3 step scale ( contained none, moderate and high)
2
Description
Incidence of dysphagia following intubation
Timepoint
1,6,24,48 hours after ooperation
Method of measurement
By interview and by a 3 step scale ( contained none, moderate and high)
Intervention groups
1
Description
One group will be intubated by Macintosh laryngoscope.Intubation will be done by tube number 7 or 7.5. Cuff tube will be adjusted between 20-25 mmHg. Patients’ general anesthesia will be induced and maintained in a similar protocol. Patients will be extubated deeply. After operation patients for sore throat will be questioned and interviewed in times: 1, 6, 24 and 48 hours by a 3 steps scale (contained none, moderate and high).
Category
Other
2
Description
The other group will be intubated by Glidescope. Intubation will be done by tube number 7 or 7.5. Cuff tube will be adjusted between 20-25 mmHg. Patients’ general anesthesia will be induced and maintained in a similar protocol. Patients will be extubated deeply. After operation patients for sore throat will be questioned and interviewed in times: 1, 6, 24 and 48 hours by a 3 steps scale (contained none, moderate and high).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Farsad Imani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farsad Imani
Street address
Keshavarz Blvd, Qods St. Cross
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Shirin Habibi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini St., Hassan Abad Square, Sina Hospital
City
Tehran
Postal code
Phone
+98 217831157
Fax
Email
shirin_habibi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Atabak Najafi
Position
Associate Professor
Other areas of specialty/work
Street address
Keshavarz Blvd, Qods St. Cross
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
anadjafi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr shirin Habibi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini St., Hassan Abad Square, Sina Hospital
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
shirin_habibi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)