Comparison of postoperative complication rates after Diagnostic laparoscopy in infertile women between the two methods of endotracheal intubation and a laryngeal mask Classic
The purpose of this study is to Comparison of postoperative complication rates after Diagnostic laparoscopy in infertile women between the two methods of endotracheal intubation and a Classic laryngeal mask. In this randomized single blinded clinical trial, 160 women, ASA physical status I and II, were assigned into one of the following two groups. in group 1 Classic laryngeal mask size 3_4 according to age and in group 2 endotracheal intubation tube size 7 were used . side effects such as nausia and vomiting, hoarseness, cough and pain in air ways after , was assessed at 6, 12, and 24 hours after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022312561N1
Registration date:2014-10-27, 1393/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Mohammad hossein Jarahzadeh
Name of organization / entity
Shahid sadoughy hospital
Country
Iran (Islamic Republic of)
Phone
+98 35 1826 8697
Email address
dr.jarahzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Shahid Sadoughi University of Medical Science
Expected recruitment start date
2012-12-06, 1391/09/16
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative complication rates after Diagnostic laparoscopy in infertile women between the two methods of endotracheal intubation and a laryngeal mask Classic
Public title
Comparison of postoperative complication rates after Diagnostic laparoscopy in infertile women between the two methods of endotracheal intubation and a laryngeal mask Classic
Purpose
Treatment
Inclusion/Exclusion criteria
including criteria: infertile women under diagnostic laparoscopy by the two methods of endotracheal intubation and a Classic laryngeal mask.
excluding criteria: history of cardiovascular disease ; BMI more than 30 ; NG tube ; facial anatomical defect.
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
160
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 Sadoughi University of Medical Science
Street address
Yazd, Bahonar square, Shahid Sadoughi University of Medical Science
City
Yazd
Postal code
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
9208
Health conditions studied
1
Description of health condition studied
side effects after intubation
ICD-10 code
J95.9
ICD-10 code description
Postprocedural respiratory disorder, unspecified
Primary outcomes
1
Description
pain in airways
Timepoint
immidiately,6,12 and 24 hours after the surgery
Method of measurement
by direct asking
2
Description
nausia and vomiting
Timepoint
in 6, 12 and 12 hours after surgery
Method of measurement
by direct asking
3
Description
cough
Timepoint
in 6, 12 and 24 hours after the surgery
Method of measurement
by direct asking
Secondary outcomes
empty
Intervention groups
1
Description
group 1: classic laryngeal mask
Category
Other
2
Description
group 2: endotracheal intubation
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Mohammad Hossein Jarahzadeh
Street address
Yazd, Ebnesina Blv, Shahid Sadoughi Hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research -Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr Mozaffari
Street address
Yazd, Bahonar square,Shahid Sadoughi University
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research -Shahid Sadoughi 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 Sadoughi University of Medical Science
Full name of responsible person
Dr Mohammad Hossein Jarahzadeh
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Yazd, Shahid Sadoughi Hospital
City
Yazd
Postal code
8915887857
Phone
+98 35 1822 4000
Fax
Email
dr.jarahzadeh@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr Mohammad Hossein Jarahzadeh
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Yazd, Ebnesina Blv, Shahid Sadoughi Hospital
City
Yazd
Postal code
89158878857
Phone
+98 35 1822 4000
Fax
Email
dr.jarahzadeh.ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr Mohammad Hossein Jarahzadeh
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Yazd, Ebnesina Blv, Shahid Sadoughi hospital
City
Yazd
Postal code
8915887857
Phone
+98 35 1822 4000
Fax
Email
dr.jarahzadeh@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)