Protocol summary

Study aim
Determining and comparing the duration and complications of anesthesia over time after using a laryngeal mask and tracheal tube in patients undergoing hand reconstruction surgery.
Design
To assign patients to each of the two intervention groups, based on the patient code and random number table, patients are assigned to one of the two tracheal tube or laryngeal mask groups. To calculate the sample size, 45 people are considered in each group. In this study, people will be divided into two groups, laryngeal mask and tracheal tube, by a person knowledgeable about the type of airway control, giving codes to patients and taking into account the entry and exit criteria.
Settings and conduct
Place of operation: operating room of Ashayer Khorramabad Hospital This study is a single-blind clinical trial. Dividing people into two groups, laryngeal mask and tracheal tube During the surgery, using a checklist, the patient's age, gender, type of surgery, duration of anesthesia and vital signs will be recorded in 4 different times before anesthesia, 10 and 20 minutes after the start of the surgery, in the recovery department of the operating room. became.
Participants/Inclusion and exclusion criteria
Entry requirements: patients undergoing hand repair surgery Patients aged 18-60 years Patients with ASA Ⅰ,Ⅱ Patients' consent to participate in the plan; Conditions of non-entry: presence of congenital diseases of the jaw and face Pregnant patients Abnormal airway anatomy Hemodynamic changes such as increased blood pressure
Intervention groups
Laryngeal mask group Tracheal tube group
Main outcome variables
the amount of sore throat; satisfaction; duration of anesthesia; systolic blood pressure; diastolic blood pressure; oxygen saturation; heart beat; breathing rate; The incidence of cardiac arrhythmias after using a laryngeal mask and tracheal tube varies over time.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240721062495N1
Registration date: 2024-07-30, 1403/05/09
Registration timing: prospective

Last update: 2024-07-30, 1403/05/09
Update count: 0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Kian Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3332 4132
Email address
kiankarami23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of laryngeal mask and tracheal tube on duration and complications of anesthesia in reconstructive hand surgery patients
Public title
Study of the effects of various airway preservation methods on anesthesia complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hand reconstruction surgery Patients aged 18-60 years Patients with ASA class Ⅰ-,Ⅱ Patients' consent to participate in the study
Exclusion criteria:
Congenital diseases of the jaw and face Pregnant patients Abnormal airway anatomy Gastric aspiration during surgery Hemodynamic changes such as increased blood pressure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done through a table of random numbers. That is, the exact number of patients is specified and a code is assigned to each patient. Then, based on the patient code and the table of random numbers, the patients are assigned to one of the two groups of tracheal tube or laryngeal mask by the computer.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a one-blind clinical trial study in such a way that the patient is unaware of the type of respiratory assistance intervention. In other words, the information that can distort the test result remains hidden from the participant's view, but the person responsible for conducting the test is aware of them.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
No.87, East 1 Souzani Alley, Kheirabad Ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6814715568
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.LUMS.REC.1403.130

Health conditions studied

1

Description of health condition studied
Examination of the airway during anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determining and comparing the duration and complications of anesthesia over time after using laryngeal mask and tracheal tube in patients undergoing hand reconstruction surgery.
Timepoint
Laryngeal mask - tracheal tube
Method of measurement
observasion

2

Description
Measurement time
Timepoint
Before anesthesia, 10 and 20 minutes after anesthesia, recovery room
Method of measurement
observation

3

Description
Age
Timepoint
Number of years of life
Method of measurement
interview

4

Description
Sore throat
Timepoint
Recovery
Method of measurement
Feeling of pain by the patient (Likert scale) Visual Analogue Scale

5

Description
Duration of anesthesia
Timepoint
before the time of intervention until the end of anesthesia
Method of measurement
Stopwatch

6

Description
Systolic blood pressure
Timepoint
Before anesthesia, 10 and 20 minutes after surgery, recovery room
Method of measurement
Medical sphygmomanometer

7

Description
Diastolic blood pressure
Timepoint
Before anesthesia, 10 and 20 minutes after surgery, recovery room
Method of measurement
Medical sphygmomanometer

8

Description
heart rate
Timepoint
Before anesthesia, 10 and 20 minutes after surgery, recovery room
Method of measurement
Anesthesia monitor device

9

Description
Breathing rate
Timepoint
Before anesthesia, 10 and 20 minutes after surgery, recovery room
Method of measurement
Anesthesia monitor device

10

Description
Blood oxygen saturation
Timepoint
Before anesthesia, 10 and 20 minutes after surgery, recovery room
Method of measurement
Anesthesia monitor device (Pulse oximeter)

11

Description
Occurrence of cardiac arrhythmia
Timepoint
Before anesthesia, 10 and 20 minutes after surgery, recovery room
Method of measurement
Anesthesia monitor device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tracheal tube
Category
Other

2

Description
Intervention group: Laryngeal mask
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
shohadaye Ashayer hospital
Full name of responsible person
Behrouz Farzan
Street address
Enghelab Ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6816989965
Phone
+98 66 3323 6401
Email
Bimarestanshohadaashayer@email.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Kamarehie
Street address
Kamalvand Ave, Khorramabad town
City
khorramabad
Province
Lorestan
Postal code
6814715568
Phone
+98 66 3312 0172
Email
reaserch@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kian Karami
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
No.78, East Souzani 1 Alley, Kheirabad Ave, Korramabad
City
Khoramabad
Province
Lorestan
Postal code
6814715568
Phone
+98 66 3332 4132
Fax
Email
kiankarami23@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kian Karami
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
No.78, East Souzani 1 Alley, Kheirabad Ave, Korramabad
City
Khoramabad
Province
Lorestan
Postal code
6814715568
Phone
+98 66 3332 4132
Fax
Email
kiankarami23@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kian Karami
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
No.78, East Souzani 1 Alley, Kheirabad Ave, Korramabad
City
Khoramabad
Province
Lorestan
Postal code
6814715568
Phone
+98 66 3332 4132
Fax
Email
kiankarami23@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...