Protocol summary

Summary
The aim of this study is Comparison of i-Gel and Air-Qsp for airway management in patients under general anaesthesia and comparison time airway instrument of insertion and peak airway pressure. This is a single-blind study in 40 patient in both gender with ASA class I and II and our study anaesthetized paralysed patients who candidate for minor elective surgery in Shahid Modares Hospital.The patients will randomly be allocated into 2 groups with Table of random numbers. First group airway will manage with I-gel(n=20) and second with Air-Q(n=20).The patients will be blind in this study. Inclusion criteria patient underwent elective operation who required general anaesthesia with neuromuscular blocker under ventilator support, ASA Class III, Age18_70, Consented, Inguinal hernia Surgery, varicocele surgery.Exclusion criteria Cardiac disease with ASA III_IV, Age older than 70 or younger than18, Requires urgent operation, Prolong Operation( lasted more than 2 hours ). Prior to anaesthetic induction a 18 intravenous catheter will be inserted to give fluid and medication. After induction with Propofol 2.5mg/kg and atracurium, 0.5mg/kg the supraglottic device will be inserted and anaesthesia technician will measure the time of insertion.After that, manual ventilation will consider for leak pressure test and will register high pressure with the air leak and patient ventilate under control ventilation with Tidal volume=5-6 cc/kilogram, Rate=12, Pressure Maximum=25 cmH2O.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081512203N8
Registration date: 2017-10-07, 1396/07/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-07, 1396/07/15
Registrant information
Name
Niloufar Massoudi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 6961
Email address
nmasoudi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of medical science
Expected recruitment start date
2017-05-26, 1396/03/05
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of i-Gel and Air-Qsp for airway managment in patients under general anesthesia.
Public title
Comparison of i-Gel and Air-Qsp for airway management in patients under general anesthesia.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patient underwent elective operation who required general anaesthesia with neuromuscular blocker under ventilator support,ASA Class I –II,Age18_70,Consented, Inguinal hernia Surgery,varicocele surgery. Exclusion criteria:Cardiac disease with ASA III_IV,Age older than 70 or younger than18,Requies urgent operation,Prolong Operation( lasted more than 2 hours )
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 0
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shahid Bheshti University of Medical Sciences.
Street address
Shahid Beheshti Medical university, Arabi street, Velenjak.
City
Tehran
Postal code
Approval date
2017-05-24, 1396/03/03
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.129

Health conditions studied

1

Description of health condition studied
Inguinal hernia surgery
ICD-10 code
K40
ICD-10 code description
Bilateral inguinal hernia, with obstruction, without gangrene

2

Description of health condition studied
Scrotal varices surgery
ICD-10 code
I86.1
ICD-10 code description
dilated tortuous veins of the spermatic cord

Primary outcomes

1

Description
maximum inspiration pressure that exist leak
Timepoint
first second and 30 minute after start of surgery
Method of measurement
cmHg

Secondary outcomes

1

Description
End expiratory carbon dioxide pressure
Timepoint
first second and 30 minute after start of surgery
Method of measurement
capnography

Intervention groups

1

Description
Intervention:Use of Air-Q
Category
Treatment - Other

2

Description
Control Group:Use of I-Gel
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Nilofar Massoudi
Street address
Shahid Modares Hospital, Sadat Abad.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for the research Shahid Beheshti University of Medical Science.
Full name of responsible person
Nilofar Massoudi
Street address
Shahid Modares Hospital,Shahid Beheshti Medical Science University,Sadat Abad, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for the research Shahid Beheshti University of Medical Science.
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
Shahid Behesti Medical University
Full name of responsible person
Nilofar Massoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Beheshti Mediacal University, Modares Hospital, Sadat Abad.
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
massodi@sbmu.ac.ir, fsafari@sbmu.ac.ir, alidabbagh@sbmu.ac.ir.
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Behesht University of Medical Science
Full name of responsible person
Nilofar Massoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Behesht University of Medical Science, Modares Hospital. Sadat Abad.
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
massodi@sbmu.ac.ir, fsafari@sbmu.ac.ir, alidabbagh@sbmu.ac.ir.
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Behesht University of Medical Science
Full name of responsible person
Nilofar Massoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Behesht University of Medical Science, Modares Hospital, Sadat Abad.
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
massodi@sbmu.ac.ir, fsafari@sbmu.ac.ir, alidabbagh@sbmu.ac.ir.
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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