This study will be conducted to compare the impact of the use of supraglottic airway and classic laryngeal mask in children undergoing surgery with general anesthesia. This randomized trial will study 60 children aged six months to six years undergoing elective hernia or hydrocele surgery referred to Dr. Sheikh Hospital in Mashhad, Iran. The patients randomly will be divided into two groups of 30 subjects (intervention and control group). The main inclusion criteria: children aged six months to six years old undergoing hernia or hydrocele in supine position. Exclusion criteria: intraoperative problems; problems during tracheal intubation; prolonged surgery. During anesthesia for tracheal intubation, supraglottic airway will be used for intervention group and classic laryngeal mask for control group. Finally, intraoperative indicators (blood on the device, maximum airway pressure, end-tidal CO2) and postoperative complications in recovery (cough, sore throat, nausea, vomiting, dyspnea, dysphagia) will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091726858N4
Registration date:2016-10-08, 1395/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-08, 1395/07/17
Registrant information
Name
Toktam Kianian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 1415
Email address
drnm@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of using supraglottic airway and classic laryngeal mask among children underwent surgery with general anesthesia
Public title
Comparison of the effects of using supraglottic airway and classic laryngeal mask among children underwent surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the age of six months to six years; elective hernia or hydrocele surgery in supine position; no respiratory diseases and airway problems; no obstructive sleep apnea; no regurgitation; non-emergency surgery; no history of surgery on the abdomen and chest and BMI less than 30.
Exclusion criteria: problems during surgery; problems during tracheal intubation and prolonged surgery (more than one hour).
Age
From 6 months old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghorayshi Building, Daneshgah Street, Mashhad University of Medical Sciences
City
Mashhad
Postal code
9138813944
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.MUMS.fm.REC.1395.60
Health conditions studied
1
Description of health condition studied
hernia
ICD-10 code
K40,K40.0,
ICD-10 code description
Inguinal hernia, Bilateral inguinal hernia, with obstruction, without gangrene, Bilateral inguinal hernia, with gangrene, Bilateral inguinal hernia, without obstruction or gangrene, Unilateral or unspecified inguinal hernia, with obstruction, without gang
2
Description of health condition studied
hydrocele
ICD-10 code
N43.3
ICD-10 code description
hydrocele of spermatic cord, testis or tunica vaginalis
Primary outcomes
1
Description
Maximum airway pressure
Timepoint
Intraoperative
Method of measurement
Ventilator
2
Description
Blood on equipment
Timepoint
Intraoperative
Method of measurement
Observation
3
Description
Sore Throat
Timepoint
Postoperative
Method of measurement
Interviews with patients
4
Description
End-Tidal CO2
Timepoint
Intraoperative
Method of measurement
Ventilator
5
Description
Cough
Timepoint
Postoperative
Method of measurement
Observation and interviews with patients
6
Description
Nausea
Timepoint
Postoperative
Method of measurement
Interviews with patients
7
Description
Vomit
Timepoint
Postoperative
Method of measurement
Interviews with patients
8
Description
Shortness of breath
Timepoint
Postoperative
Method of measurement
Interviews with patients
9
Description
Dysphagia
Timepoint
Postoperative
Method of measurement
Interviews with patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the proper depth of anesthesia, appropriate size of supraglottic airway based on the child weight and the manufacturer's instructions will be selected and placed by an anesthesiologist with experience in placement of supraglottic equipment.
Category
Prevention
2
Description
Control group: in the proper depth of anesthesia, appropriate size of classic laryngeal mask based on the child weight and the manufacturer's instructions will be selected and placed by an anesthesiologist with experience in placement of supraglottic equipment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shaikh Hospital
Full name of responsible person
Dr Mohammad Garavi Fard
Street address
Taheri Street, Touhid Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Department of pharmaceutics,School of pharmacy, Pardis of University, Azadi Square, Mashhad,
City
Mashhad
Grant name
1
Grant code / Reference number
1
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe Kerman Saravi
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3341 1415
Fax
+98 54 3344 2481
Email
f_kermansaravi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Dr Shahram Amini
Position
ICU fellowship, anesthesiologist
Other areas of specialty/work
Street address
Emam Reza hospital, Emam Reza square, Ebne Sina street
City
Mashhad
Postal code
Phone
+98 51 3802 2314
Fax
+98 51 3802 2314
Email
aminish@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe Kerman Saravi
Position
MSc in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Square
City
Zahedan
Postal code
43463-98167
Phone
+98 54 3343 8473
Fax
Email
t.kianian67@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)