comparing the use of tracheal tube size 7.5 and 6.5 in men and 7 and 6 in women during laparoscopic surgery in terms of reducing the incidence of sore throat and hoarseness after intubation
Determining the amount of sore throat and voice harshness after surgery following the use of tracheal tube size 6.5 instead of 7.5 in men and size 6 instead of 7 in women during laparoscopic surgery.
Design
In this study, all patients with a fixed drug regimen including propofol, atracurium, sufentanil and midazolam are under anesthesia, and propofol, remifentanil and atracurium are also used during anesthesia.The settings of the anesthesia machine are also done by the anesthesiologist based on the patient's weight and ETCO2 during anesthesia. Laryngoscopy procedure with Mackintosh blade is performed by a trained anesthesiology resident with at least two years of experience or an anesthesiologist, and the Cormack-Lehan grade is recorded by them.
In this study, patients are randomly assigned to the intervention and control groups based on the last digit of the case number, whether it is an even number or an individual.
Settings and conduct
Hospitals of Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients aged 18 to 60 who are candidates for laparoscopic surgery with a BMI below 35 referring to Qaim (AH) and Imam Reza (AS) hospitals, who are in the clinical status of ASA I and II.
Intervention groups
For male patients, tracheal tube number 7.5 will be placed in the control group and tracheal tube number 6.5 in the test group.
Tracheal tube number 7.0 will be placed in female patients of the control group and tracheal tube number 6.0 in female patients of the test group.
Main outcome variables
Assessment of postoperative sore throat and voice severity (according to the patient's statement)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230825059253N1
Registration date:2024-02-03, 1402/11/14
Registration timing:retrospective
Last update:2024-02-03, 1402/11/14
Update count:0
Registration date
2024-02-03, 1402/11/14
Registrant information
Name
Pooria Namaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 2776
Email address
namaeip4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the use of tracheal tube size 7.5 and 6.5 in men and 7 and 6 in women during laparoscopic surgery in terms of reducing the incidence of sore throat and hoarseness after intubation
Public title
The effect of reducing the size of the intubation tube on the amount of sore throat after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years old candidates for laparoscopic surgery
BMI below 35
ASA I or II clinical status.
Exclusion criteria:
history of allergies and respiratory diseases
history of respiratory infection during the last month
History of cold or respiratory infection in the last month
History of esophageal reflux
Patients who fall into four Cormak-Lehane classifications during laryngoscopy
Any disturbance in hemodynamics or oxygen delivery to the patient during anesthesia
Need more than two laryngoscopy directions for intubation Even in patients with a BMI below 35, if re-intubation is needed due to the need to replace the tracheal tube due to overinflation
Patients whose surgery lasts more than 3 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is done based on the last digit of the file number, and in patients with an even file number, a larger tube size is used, and in patients with an odd file number, a smaller tube size is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the study participants are unaware of the size of the tube used, and due to the fact that the variable is the size of the tube, there is no possibility of blinding the clinical caregiver.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Educational, Research and Treatment Center of Imam Reza Hospital - Mashhad University of Medical Sci
Evaluation of postoperative sore throat and voice severity (according to the patient's statement)
Timepoint
at 1, 6, and 24 hours after surgery
Method of measurement
based on VAS criteria
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group consists of men who meet the conditions for entering the study, for whom we place an endotracheal tube number 6.5, which are compared with the control group of men who are placed with an endotracheal tube number 7.5.
Category
Treatment - Devices
2
Description
Intervention group: The second intervention group includes women who meet the conditions for entering the study, for whom we place an endotracheal tube number 6, which are compared with the control group of women who are placed with an endotracheal tube number 7.
Category
Treatment - Devices
3
Description
Control group: The first control group of men with conditions for entering the study, for whom we place an endotracheal tube No. 7.5, which are compared to the first intervention group for which we place an endotracheal tube No. 6.5.
Category
Treatment - Devices
4
Description
Control group: The second control group of women with conditions to enter the study, for whom we place an endotracheal tube number 7, which are compared to the second intervention group for which we place an endotracheal tube number 6.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Mashhad University of Medical Sciences
Full name of responsible person
Pooria Namaei
Street address
Shahid Kaveh Blvd. - Malek Shaara St. - Anuri St. - Anuri 2 - No. 20
City
mashhad
Province
Razavi Khorasan
Postal code
9177795915
Phone
+98 51 3840 2776
Email
namaeip4001@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research assistant of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Medical Sciences, 3rd floor, University Research and Technology Vice-Chancellor, University of Medical Sciences, University of Medical Sciences, University of Medical Sciences, University Street, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177795915
Phone
+98 51 3841 1838
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Pooria Namaei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kaveh Blvd., Anuri St., Anuri 2, No. 20
City
Mashhad
Province
Razavi Khorasan
Postal code
9177795915
Phone
+98 51 3840 2776
Email
namaeip@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Tabari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3843 3999
Email
tabarim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Moradi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3843 3999
Email
moradia@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be published in the form of a research plan after deidentifying the individuals, which includes all the variables and outcomes of the study.
When the data will become available and for how long
After collecting the data and analyzing the statistics, which is about the year 1403, it will be published in the form of a research project.
To whom data/document is available
The data is accessible to all people, including researchers, institutions, universities, and industrial companies
Under which criteria data/document could be used
The information and results of the study and data are accessible to other researchers on the condition of mentioning the source of the information and data
From where data/document is obtainable
In order to receive the data, one should be in contact with the direct manager of the project, Mr. Dr. Pouria Namei, with the email address namaeip4001@mums.ac.ir, and if there are necessary conditions, the information will be provided to the people.
What processes are involved for a request to access data/document
If there is a request, an official letter of request and conditions should be sent to the email address namaeip4001@mums.ac.ir. If the necessary conditions are met, correspondence will be done with the person or institution within a week through this email to send the data.