In this double-blind clinical trial, 124 patients aged 19 to 63 years under general anesthesia are randomly divided into intervention and control groups in case of hoarseness, no history of laryngeal surgery, and no abnormal position during operation. Patients will be excluded from the study in case of sore throat, straining, coughing during extubation and hard intubation. The intervention group will be intubated with softened endotracheal tube warmed up in 45 degrees centigrade normal saline for 5 minutes and the control group is intubated with not warmed up endotracheal tube. After anesthesia, intubation will be performed with the Supa-Tehran PVC endotracheal tube (No. 7-8 for men and 6.5-7.5 for women). Anesthesia continues with propofol, fentanyl and atracurium. The mechanical ventilation will begin with the initial tv of 10 mL/kg and the respiratory rate of 10/minute and will be adjusted with normocapnia. The effect of relaxant drugs will be reversed with Neostigmine and Atropine. When the spontaneous breathing is appropriate and the patient is able to perform oral instructions, endotracheal extubation is done immediately after suction. An airway will be inserted before the endotracheal extubation. All patients will be screened for sore throat and hoarseness severity after recovery, 2, 12 and 24 hours after surgery by an informed nurse. The severity of sore throat and hoarseness is graded and information is recorded and will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708294365N22
Registration date:2017-10-21, 1396/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Mazandaran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of warm endotracheal tube insertion on post operation sore throat and hoarseness
Public title
Effect of warm endotracheal tube insertion on post operation sore throat and hoarseness
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Not having sore throat and clear hoarseness; no history of previous surgery of the larynx; absence of abnormal position during surgery.
Exclusion criteria:
Toughness; Coughing during extubation; Hard intubation (more than 2 times laryngoscopy); Nasogastric tube fixation; N2O
Age
From 19 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem square, Sari
City
Sari
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.96.3011
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
J02
ICD-10 code description
Acute pharyngitis
2
Description of health condition studied
Hoarseness
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
Primary outcomes
1
Description
Sore throat
Timepoint
immediately, 2 hrs, 12 hrs and 24 hrs after operation
Method of measurement
Scale of sore throat (0 without sore throat, 1 low, 2 medium, 3 severe)
2
Description
Hoarseness
Timepoint
immediately, 2 hrs, 12 hrs and 24 hrs after operation
Method of measurement
Scale of hoarseness (0 without sore throat, 1 low, 2 medium, 3 severe)
Secondary outcomes
empty
Intervention groups
1
Description
Intubation will be performed with the Supa-Tehran PVC endotracheal tube (No. 7-8 for men and 6.5-7.5 for women). The control group is intubated with not warmed up endotracheal tube
Category
Placebo
2
Description
Intubation will be performed with the Supa-Tehran PVC endotracheal tube (No. 7-8 for men and 6.5-7.5 for women). The intervention group will be intubated with softened endotracheal tube warmed up in 45 degrees centigrade normal saline for 5 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Sari
Full name of responsible person
Afshin Gholipour Baradari, MD
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology of Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi, MD
Street address
Moallem Square, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sahar Besharatdeh
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Imam Khomeini hospital, Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
sahar.besharat63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem square, Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
gholipourafshin@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem square
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
azamani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)