The aim of current study is to compare airway management procedures including laryngeal mask airway (LMA) and endotracheal tube (ETT) in patients undergoing strabismus surgery that is associated with lower incidence of postoperative nausea and vomiting. The samples were 160 patients who were candidate for strabismus surgery in Khatamolanbya hospital of Mashhad University of Medical Sciences. This research was a single blind clinical trial, the recovery and ward staff members and also the statistical specialist were totally unaware of assigning the patients in two groups. Patients were divided into two equal groups of 80, based on random allocation table. Laryngeal mask airway (LMA) was used in one group and endotracheal tube (ETT) in the other one. Anesthesia induction and its maintenance were similar for all patients. All patients underwent cardiac monitoring, noninvasive blood pressure, pulse oximetry and capnography. At the end of surgery after endotracheal extubation or laryngeal mask airway removal, patients were transferred to the recovery room then patients were assessed at 24 hours for postoperative nausea and vomiting. The inclusion criteria included: aged over three years, being in the class of I-II of ASA and the exclusion criteria included: having a history of nausea and vomiting after the previous surgery, having a history of motion disease and antiemetic drug consumption 24 hours before surgery. Main variable in this study was the severity of nausea and vomiting which was measured by verbal rating scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020216449N1
Registration date:2014-03-25, 1393/01/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Bahareh Dalir
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
dalirb901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
myself
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the incidence of postoperative nausea and vomiting in strabismus surgery using laryngeal mask airway and endotracheal intubation
Public title
A study of airway management on the incidence of nausea and vomiting after surgery
Purpose
Other
Inclusion/Exclusion criteria
The inclusion criteria included: aged over three years, being in the class of I-II of ASA and the exclusion criteria included: having a history of nausea and vomiting after the previous surgery, having a history of motion disease and antiemetic drug consumption 24 hours before surgery.
Age
From 3 years old to 53 years old
Gender
Both
Phase
N/A
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 Mashhad University of Medical Sciences
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
9177948564
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
910843
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
the severity of nausea and vomiting
Timepoint
after surgery in the recovery room, 6 hours after surgery, 18 hours after surgery
Method of measurement
Data collection tool was a questionnaire and verbal rating scale was used to measure.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: laryngeal mask airway (Green Medical Company, Japan) was placed (Weight based size based on factory recommendation) in the airway of patients.
Category
N/A
2
Description
Intervention 2: endotracheal tube (Supa Company, Iran) was placed (Weight based size based on factory recommendation) in the airway of patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbya hospital of Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Dalir
Street address
Khatamolanbya hospital of Mashhad University of Medical Sciences, Abootaleb crossroads, Kolahdooz Ave. Mashhad, Khorasan Razavi, Iran
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
Mohsen Tafaghodi
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
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, 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
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Dalir
Position
anesthesiology resident
Other areas of specialty/work
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
9177948564
Phone
+98 51 1852 5209
Fax
+98 51 1852 5209
Email
dalirb901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Dalir
Position
anesthesiology resident
Other areas of specialty/work
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
9177948564
Phone
+98 51 1852 5209
Fax
+98 51 1852 5209
Email
dalirb901@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Dalir
Position
anesthesiology resident
Other areas of specialty/work
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
9177948564
Phone
+98 51 1852 5209
Fax
+98 51 1852 5209
Email
dalirb901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)