Protocol summary

Study aim
This study was designed to investigate the effect of intracuff local anesthetics on emerging reactions after general anesthesia.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 350 patients. Random card selection method is used for randomization.
Settings and conduct
In the operating room of Imam Hossein (AS) Hospital in Tehran, before performing anesthesia, an anesthesia technician, without informing the anesthesiologist and the patient, uses a random selection of a card to identify the patient group and one of the syringes containing one of the drugs in each group. Submits to the anesthesiologist and records this information separately. At the end of the surgery, the questionnaire is delivered to the first technician. Information outside the operating room is tracked by the same anesthesiologist.
Participants/Inclusion and exclusion criteria
All patients over 18 years of age with physical condition I or II of the American Society of Anesthesiologists (ASA) who undergo elective limb surgery under general anesthesia for one to three hours by endotracheal intubation in a supine position are included in the study. To be. Patients with a history of sore throat, hoarseness or cough, moderate to severe illness, recent respiratory infection, history of airway prolapse, long history of intubation, smokers and illicit drug users, difficult to predict intubation, risk of aspiration Stomach contents, history of tracheal or laryngeal surgery, BMI> 30.0, use of a nasogastric tube or nasal or oral airway will be excluded.
Intervention groups
After endotracheal intubation, the endotracheal tube cuff will be filled in one of the following ways: air, isotonic saline, ropevacaine, bupivacaine, lidocaine.
Main outcome variables
Cough; Sore throat; bucking on the endotracheal tube

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010800N4
Registration date: 2022-04-23, 1401/02/03
Registration timing: registered_while_recruiting

Last update: 2022-04-23, 1401/02/03
Update count: 0
Registration date
2022-04-23, 1401/02/03
Registrant information
Name
Dariush Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2611
Email address
d.abtahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-20, 1401/01/31
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of intracuff ropivacaine, bupivacaine, and lidocaine on emergence reactions after general anesthesia
Public title
Evaluation of the effect of using local anesthetics inside the endotracheal tube cuff on emergence reactions from anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years old Consent to the study Performing general anesthesia using endotracheal intubation
Exclusion criteria:
Drug abuse Existence of uncontrolled underlying disease Pre-existing sore throat Pre-existing hoarseness Pre-existing cough Recent respiratory infection History of hyperactive airways History of prolonged intubation Anticipated difficult intubation Risk of aspiration of gastric contents
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 350
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are grouped by a simple randomization method using a random selection of one of the five cards, each of which is named after one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before performing anesthesia, an anesthesia technician, without the knowledge of the anesthesiologist and the patient, uses a random selection of a card to identify the patient group and deliver one of the syringes containing one of the drugs in each group to the anesthesiologist and record this information separately. At the end of the surgery, the questionnaire is delivered to the first technician. Information outside the operating room is tracked by the same anesthesiologist.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University
Street address
Emam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.032

Health conditions studied

1

Description of health condition studied
Cough, sore throat, and hoarseness after extubation
ICD-10 code
T88.9XXA
ICD-10 code description
Complication of surgical and medical care, unspecified, initial encounter

Primary outcomes

1

Description
Cough
Timepoint
At zero, ten minutes, thirty minutes, 6 hours, and 24 hours after extubation
Method of measurement
Anesthesiologist observation to determine its presence and severity (mild: less than 5 coughs, moderate: more than 5 coughs, severe: frequent coughs that prevent the patient from breathing normally)

2

Description
Sore throat
Timepoint
At zero, ten minutes, thirty minutes, 6 hours, and 24 hours after extubation
Method of measurement
Patient self-reported based on either three, moderate, or severe levels.

3

Description
Hoarseness
Timepoint
At zero, ten minutes, thirty minutes, 6 hours, and 24 hours after extubation
Method of measurement
Observe an anesthesiologist by determining its presence and severity (mild: ability to speak easily with slight change in voice, moderate: difficulty speaking, severe: complete hoarseness)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the air group, the endotracheal tube's cuff will be filled with a minimum volume of air so that no sound of air leakage can be heard.
Category
Placebo

2

Description
Intervention group: In the isotonic saline solution group, the cuff of the endotracheal tube will be filled with a minimum volume of isotonic saline solution so that no air leakage sound can be heard.
Category
Treatment - Drugs

3

Description
Intervention group: In the ropivacaine group, the endotracheal tube's cuff will be filled with a minimum volume of 0.5% ropivacaine so that no air leakage can be heard.ine
Category
Treatment - Drugs

4

Description
Intervention group: In the bupivacaine group, the endotracheal tube's cuff will be filled with a minimum volume of 0.5% bupivacaine so that no air leakage can be heard.ine
Category
Treatment - Drugs

5

Description
Intervention group: In the lidocaine group, the endotracheal tube's cuff will be filled with a minimum volume of 2% lidocaine so that no air leakage can be heard.ine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Emam Hossein
Full name of responsible person
Dariush Abtahi
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drdariushabtahi@yahoo.com
Web page address
https://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshhin Zarghi
Street address
Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Web page address
https://en.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2263 2611
Fax
Email
d.abtahi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital. Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009812277567840
Email
drdariushabtahi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital. Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drdariushabtahi@yahoo.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
One year after the publication of the article.
To whom data/document is available
All jobs
Under which criteria data/document could be used
All non-personal patient information (anonymously) can be accessed by contacting the responsible author.
From where data/document is obtainable
email to: drdariushabtahi@yahoo.com
What processes are involved for a request to access data/document
Sending email and review by the responsible author
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