Investigating the effect of tracheal tube cuff pressure balancing in preventing sore throat and hoarseness in general anesthesia using nitrous oxide in surgery in supine and prone positions
Investigating the effect of tracheal tube cuff pressure balancing in preventing sore throat and hoarseness in general anesthesia using nitrous oxide in surgery in supine and prone positions
Design
The study will be double blind and clinical trial.212 patients will be randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Candidates for general anesthesia in Valiasr hospital in Arak city are divided into 4 groups by simple randomization using the block method. The study is double-blind and blinding of the analyst and the outcome evaluator and the participant is done.All intubations will be performed by the anesthesia resident.Adjusting the tracheal tube cuff pressure will be done by supervisor. The follow-up of patients and recording of information and completion of the checklist will be done by resident.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age 30 to 60 years; no history of chronic use of painkillers; insensitivity to nitrous oxide; failure to perform laparoscopic surgery; absence of upper airway infection and colds; no need to use NG-tube during surgery and up to 24 hours after surgery; the duration of surgery should not be less than 60 minutes and not more than 120 minutes; consent to participate in the study
Exclusion criteria: the patient's lack of consent to continue participating in the study; observing blood during suction when removing the tracheal tube; for any reason, we have to perform laryngoscopy twice on the patient.
Intervention groups
Patients will be divided into four groups. In the intervention groups, oxygen and N2O with a concentration of 50:50 are prescribed in prone and supine positions. In the control group, oxygen and air are prescribed as 50:50 with two positions, prone and supine.
Main outcome variables
Sore throat, voice harshness, average propofol consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N187
Registration date:2023-07-19, 1402/04/28
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of tracheal tube cuff pressure balancing in preventing sore throat and hoarseness in general anesthesia using nitrous oxide in surgery in supine and prone positions
Public title
Investigating the effect of tracheal tube cuff pressure balancing in preventing sore throat and hoarseness in general anesthesia using nitrous oxide in surgery in supine and prone positions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 60 years
ASA class I and II
No history of sore throat before surgery
No history of drug use
No history of chronic use of painkillers
Insensitivity to nitrous oxide
Failure to perform laparoscopic surgery
Absence of upper airway infection and colds
Absence of malampati more than 2
No need to use NG-tube during surgery and up to 24 hours after surgery
The duration of surgery should not be less than 60 minutes and not more than 120 minutes
Consent to participate in the study
Exclusion criteria:
The patient's lack of consent to continue participating in the study
Observing blood during suction when removing the tracheal tube
For any reason, we have to perform laryngoscopy twice on the patient.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the specialized assistant does not know about the prescribed drugs, and the follow-up of the patients is with the anesthesiology resident, and the analyst does not know about the grouping, and as a result, the study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.ARAKMU.REC.1402.064
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Sore throat
Timepoint
Recovery and 2, 4, 8, 12 and 24 hours after the operation
Method of measurement
Pain Visual Analog scale
2
Description
Voice horsness
Timepoint
Recovery and 2, 4, 8, 12 and 24 hours after the operation
Method of measurement
Physical examination
3
Description
Mean propofol consumption
Timepoint
End of study
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Supine oxygen and N2O are prescribed with a concentration of 50:50.
Category
Treatment - Devices
2
Description
Intervention group2 : The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Perone oxygen and N2O are prescribed with a concentration of 50:50.
Category
Treatment - Devices
3
Description
control group1: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed in appropriate timings as anesthesia maintenance. In the supine position group Oxygen and air are prescribed as 50:50.
Category
Treatment - Devices
4
Description
control group 2: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Peron oxygen and air are prescribed as 50:50.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Esmaeel Moshiri
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
moshiri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davod Hekmatpou
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hekmatpou@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street