The purpose of this study is evaluation the effect comparison the effect of the I-gel with the cuffed tracheal tube in Patients undergoing laparoscopic cholecystectomy
Design
Patients will be divided into two groups by random number table. It does not apply. Study will be performed on 60 Patients.
Settings and conduct
In Urmia Imam Khomeini hospital operating room after induction of general anesthesia in operating room , either an I-gel or endotracheal tube will insert by the experienced anesthesiologists. After successful insertion, the difference between the inspired and expired tidal volumes is used to calculate the leak volume, mean airway pressure by ventilator manometer and incidence of sore throat in recovery will measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists physical status I or II, Aged 18–60 years, Elective laparoscopic cholecystectomy, general anesthesia
Exclusion criteria:
Chronic obstructive pulmonary disease, Body mass index ≥35kg/m2, Potential difficult intubation, increased risk of pulmonary aspiration, Pregnancy
Intervention groups
After induction of anesthesia, in study group an I-gel and in control group ETT will be inserted by the experienced anesthesiologists
Main outcome variables
Postoperative sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027677N10
Registration date:2019-01-21, 1397/11/01
Registration timing:retrospective
Last update:2019-01-21, 1397/11/01
Update count:0
Registration date
2019-01-21, 1397/11/01
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-05-20, 1395/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of the I-gel with the cuffed tracheal tube in Patients undergoing laparoscopic cholecystectomy
Public title
Clinical trial the effect of the I-gel with the cuffed tracheal tube in Patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists physical status I or II
Aged 18–60 years
Elective laparoscopic cholecystectomy
general anesthesia
Exclusion criteria:
Chronic obstructive pulmonary disease
Body mass index ≥35kg/m2
Potential difficult intubation
increased risk of pulmonary aspiration
Pregnancy
Ischemic heart disease
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random numbers table. In this way, the researcher gives each individual a code or a special numberThen it uses numbered numerals, and if not, list each of them on paper or small paperboard. Therefore, the number of people in the community will have a number of nuts or plaque.Then they will pour them inside a bag or container.Then remove the beads one by one, and Notices the number of them. It will continue to do so up to the number of sample numbers to choose. When the number of sample people was completed and drawings is completed, according to the list, identifies its sample people.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is one-way blind.In this study, only the patient will be unaware of which group to be assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.UMSU.REC.1394.232
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
J06.0
ICD-10 code description
Acute laryngopharyngitis
Primary outcomes
1
Description
sore throat
Timepoint
in recovery
Method of measurement
visual analog scale
Secondary outcomes
1
Description
end tidal co2
Timepoint
Before and after blowing gas
Method of measurement
capnography , mmhg
2
Description
Mean airway pressure
Timepoint
Before and after blowing gas
Method of measurement
Manometer Ventilator, Centimeter H2O
3
Description
Leak Volume
Timepoint
during surgery
Method of measurement
Difference Between Ventilation Volume At Inspiration Time And Expiration Time.This volume will be measured by a ventilator manometer.
Intervention groups
1
Description
Intervention group: insertion of i-Gel
Category
Treatment - Devices
2
Description
Control group: insertion of tracheal tube
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital, A operating room
Full name of responsible person
Shahryar Sane ,Associate Professor, Anesthesiologist