The aim of this study is to determine the cardiovascular response to Laryngeal mask insertion versus laryngoscopy and tracheal intubation. In this double blind randomized clinical trial 82 male or female with 20 to 45 years old that are scheduled for elective open limb surgery, appendectomy and inguinal herniorrhaphy at operating room in the Shahroud’s Imam Hossein hospital. After obtaining justification and consent, participants will be placed in LMA(intervention) or tracheal intubation(control) group. Management of anesthesia in both groups is identical (fentanyl premedication, induction with thiopental, muscle relaxation with atracurium and maintenance of anesthesia with isoflurane with equal proportions of oxygen and Nitrous oxide). After induction of anesthesia and muscle relaxation in intervention group, size 3 of unique singe use LMA for women and size 4 for men, and in control group Tracheal tube with size 7.5 for women and 8.0 for men will be inserted. Management of airway control in all participants will be done with standard technique and by one anesthetist. Measurable outcomes are pulse rate, systolic and diastolic blood pressure. A trained nurse charts these variables from cardiovascular monitor just before anesthesia, after induction and muscle relaxation, during airway control and then every 5 minutes during operation. A screen separates sampler from anesthetist so he(she) can’t see patient’s airway management.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052712123N6
Registration date:2016-06-18, 1395/03/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Javad Nourian
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 27 3334 2001
Email address
javadnourian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shahroud University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of Laryngeal mask insertion with conventional tracheal intubation on cardiovascular response during general anesthesia
Public title
Comparison of cardiovascular response to laryngeal mask airway versus tracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male or female; 20-45 years old; ASA class 1 or 2 (anesthesia risk ); elective limbs open surgery; hernia; appendectomy.
Exclusion criteria: Patient's refusal; hypertension; antihypertensive medication; opiate and analgesic drug abuse; every anesthesia or surgical complication.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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, Deputy of research, Shahroud University of Medical Sciences
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Postal code
3614773955
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930.31
Health conditions studied
1
Description of health condition studied
Humerus fracture
ICD-10 code
S42.3, S42
ICD-10 code description
Fracture of shaft of humerus, Fracture of lower end of humerus
2
Description of health condition studied
Fracture of both ulna and radius
ICD-10 code
S52.6, S52
ICD-10 code description
Fracture of lower end of both ulna and radius, Multiple fractures of forearm, Fracture of other parts of forearm
3
Description of health condition studied
Fracture at wrist and hand level
ICD-10 code
S62.0, S62
ICD-10 code description
Fracture of navicular [scaphoid] bone of hand, Fracture of other carpal bone(s), Fracture of first metacarpal bone, Fracture of other metacarpal bone, Multiple fractures of metacarpal bones, Fracture of thumb, Fracture of other finger, Multiple fractures
4
Description of health condition studied
Leg fracture
ICD-10 code
S82.0, S82
ICD-10 code description
Fracture of lower leg, including ankle
5
Description of health condition studied
Appendectomy
ICD-10 code
K35.3
ICD-10 code description
Acute appendicitis
6
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
before anesthesia, after induction, during airway control(laryngoscopy and intubation in control group and LMA insertion in intervention group), every five minutes during operation
Method of measurement
mmHg by Novin saadat's monitoring
2
Description
Pulse rate
Timepoint
before anesthesia, after induction, during airway control(laryngoscopy and intubation in control group and LMA insertion in intervention group), every five minutes during operation
Method of measurement
Beat per minutes by Novin saadat's monitoring
3
Description
Diastolic blood pressure
Timepoint
before anesthesia, after induction, during airway control(laryngoscopy and intubation in control group and LMA insertion in intervention group), every five minutes during operation
Method of measurement
mmHg by Novin saadat's monitoring
Secondary outcomes
1
Description
Postoperative sore throat
Timepoint
At the end of recovery and 4 hours after in ward
Method of measurement
0-3 scoring system 0-none 1- mild 2-moderate 3- severe
Intervention groups
1
Description
Intervention group: After induction of anesthesia and muscle relaxation size 3 unique singe use LMA for women and size 4 for men will be inserted cuff pressure adjusts by cuff pressure manometer.
Category
Treatment - Devices
2
Description
Control group: After induction of anesthesia and muscle relaxation laryngoscopy and intubation with size 7.5 cuffed tracheal tube for women and size 8.0 for men will be done and cuff pressure adjusts by cuff pressure manometer
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room, Imam hossein hospital
Full name of responsible person
Javad Nourian MD
Street address
Operating room, Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad hasan Emamian
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Shahroud 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
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Operating room Imam Hossein Hospital, End of Towhidi avenue Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
javadnourian@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Operating room, Imam Hossein Hospital, End of Towhidi avenue Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
javadnourian@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Operating room, Imam Hossein Hospital, End of Towhidi avenue Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
javadnourian@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)