This study is a single-blind randomized clinical trial on 320 patients at the Medical University of Arak, that have been randomly selected.
All patients needed general anesthesia for general, orthopedic, urologic and gynecological surgery.
IV LINE embedded and standard monitoring (blood pressure, heart rate and pulseoximetry) was performed for all patients.
All patients got similar drugs for general anesthesia.
Insertion of LMA or SLIPA was performed randomly, 2 min after induction of anesthesia
Laryngeal mask insertion was performed by an anesthesiologist and water-soluble gel used for lubrication.
How to insertion a laryngeal mask and insertion time is recorded.
Mechanical ventilation performed with 8 ml / kg volume and 12b/min and the fresh gas flow rate 3 L / min.
Oxygen saturation is recorded every 5 minutes until 15 minutes after anesthesia.
Air insufflations into the stomach was monitored by listening with stethoscope and recorded on three times (Immediately after insertion the mask, after 15 minutes and at the end of surgery).
Laryngeal mask is removed when the patient is breathing spontaneously, tidal volume 8 ml / kg and the verbal responses to simple stimuli.
Removing the mask could be easy or difficult that was recorded.
The patient was asked for sore throat (VAS) 30 minutes after removal of the mask. Bleeding in the throat or on the mask was recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201072080N12
Registration date:2012-03-15, 1390/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of education and research of Arak university of medical sciences
Expected recruitment start date
2010-04-17, 1389/01/28
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of the classic laryngeal mask ( LMA ) with the supralaryngeal ( SLIPA ) in general anesthesia
Public title
Comparing the effectiveness of the classic laryngeal mask ( LMA ) with the supralaryngeal ( SLIPA ) in general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing general, orthopedics, urologic and gynecologic surgery who have a need for general anesthesia; supine position; patients aged 15-70 years; ASA I - II; BMI less than 35; practice time less than one hour; preoperative fasting for at least 6 hours. Exclusion criteria: sore throat; pregnancy; history of reflux.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
320
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
Arak university of medical sciences
Street address
Alamol hoda street
City
Arak
Postal code
Approval date
2010-01-27, 1388/11/07
Ethics committee reference number
88-73-2
Health conditions studied
1
Description of health condition studied
Urologic surgery
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
2
Description of health condition studied
general surgery
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
3
Description of health condition studied
orthopedic surgery
ICD-10 code
M02
ICD-10 code description
Reactive arthropathies
4
Description of health condition studied
gynecologic surgery
ICD-10 code
O02
ICD-10 code description
Other abnormal products of conception
5
Description of health condition studied
general surgery
ICD-10 code
K60
ICD-10 code description
Fissure and fistula of anal and rectal regions
6
Description of health condition studied
general surgery
ICD-10 code
K61
ICD-10 code description
Abscess of anal and rectal regions
7
Description of health condition studied
general surgery
ICD-10 code
I84
ICD-10 code description
Haemorrhoids
Primary outcomes
1
Description
How to insertion of laryngeal mask
Timepoint
Insertion of laryngeal mask
Method of measurement
Observation
2
Description
Insertion time
Timepoint
Immediately after insertion of laryngeal mask
Method of measurement
Observation
3
Description
How to remove the laryngeal mask
Timepoint
After removing the mask
Method of measurement
Observation
Secondary outcomes
1
Description
Sorethroat
Timepoint
30 minutes after removing the mask
Method of measurement
VAS and observation
2
Description
Blood on laryngeal mask
Timepoint
After removing the mask
Method of measurement
Observation
3
Description
Gastric insufflation
Timepoint
After insertion of laryngeal mask
Method of measurement
Clinical examination
Intervention groups
1
Description
In the first 2 minutes after induction of anesthesia put LMAc and how to insert a laryngeal mask, insertion time by seconds, arterial blood saturation, the air entering the stomach , easy or difficult to remove the mask and sore throat and blood on the mask were recorded
Category
Other
2
Description
In the first 2 minutes after induction of anesthesia put SLIPA and how to insert a laryngeal mask, insertion time by seconds, arterial blood saturation, the air entering the stomach , easy or difficult to remove the mask and sore throat and blood on the mask were recorded
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valieasr hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
City
Arak
2
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
City
Arak
3
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Changizi Ashtiyani
Street address
Alamol hoda street
City
Arak
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
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
Arak university of medical sciences
Full name of responsible person
Dr.Afsaneh Norouzi
Position
Asistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valieasr hospital, Emam khomeyni street
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
norouzi43@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr.Afsaneh Norouzi
Position
Asistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valieasr hospital, Emam khomeyni street
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
norouzi43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Afsaneh Norouzi
Position
Asistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valieasr hospital, Emam khomeyni street
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
norouzi43@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)