The comparison of hemodynamic effects of the classic laryngeal mask airway, laryngeal mask airway supreme and laryngoscopy for endotracheal tube insertion in patients undergoing elective surgery.
Our aim is to compare the hemodynamic responses using three different airway devices; laryngeal mask airway Supreme (LMA-S), classic laryngeal mask airway (LMA-C) and laryngoscopy with endotracheal intubation (ETT).
This is a prospective randomized, double blind clinical trial.
Inclusion: 18-50 years old, ASA I, elective minor to moderate scale surgical operations.
Exclusion: Facial deformities and cases of difficult airway management.
The sample of 150 patients will be randomly assigned to one of these three device groups which are selected from the population of patients who are admitted to Shahid Mohammadi Hospital, Bandar Abbas, Iran.
The study will be done in one month period.
Laryngoscopy will be done with a McIntosh number 3 blade for ETT, and the other two groups' one with LMA Classic and other group with LMA Supreme.
Anesthesia induction and maintenance will be similar in all three groups.
After the airway intervention and confirming the patency of airway through the devices and the establishment of the control breathing: Blood pressure systolic and diastolic and the heart rate will be measured before induction of anesthesia and at 4 other sequential stages afterwards.
Primary outcomes: better profile with LMAs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061518091N1
Registration date:2015-05-20, 1394/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-20, 1394/02/30
Registrant information
Name
Fekrat Fereydoon
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 4009
Email address
fereydoon.fekrat@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental resources of Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of hemodynamic effects of the classic laryngeal mask airway, laryngeal mask airway supreme and laryngoscopy for endotracheal tube insertion in patients undergoing elective surgery.
Public title
Comparing the effects of different airway devices on the patients blood pressure and heart rates.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: male or female; 18-50 years old; ASA I status; elective minor to moderate scale surgical operations.
Primary exclusion criteria: emergency operations; major scale operations (neurosurgery, major thoracic and abdominal surgery); full stomach patients; BMI>35 kg/m2; patients with history of cardiovascular disease; metabolic and endocrinal pathologies that needed special care perioperatively. Patients with head and neck malformations that may cause difficult airway management.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy for Research, and Medical Ethics Committee of Hormozgan University of Medical Sciences
Street address
Joomhoori Islami Blv.,Shahid Mohammadi Hospital, Bandar Abbas, Iran.
City
Bandar Abbas
Postal code
Approval date
2014-01-22, 1392/11/02
Ethics committee reference number
HEC-92-11-2-2
Health conditions studied
1
Description of health condition studied
Laryngeal mask
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
changes in systolic and diastolic blood pressures and heart rates
Timepoint
before starting induction of anesthesia - after induction- before intervention of the airway devices- immidiately after device intervention- at times 1 ,3,5 minutes after device interventions
Method of measurement
measurments by monitor that has auotomatic NIBP and HR from the ECG monitor
Secondary outcomes
empty
Intervention groups
1
Description
Pre induction hydration was done with 7 mL/kg Ringer solution in all patients. Premedication was provided by intravenous midazolam (0.05 mg/kg) and fentanyl (2mcg/kg).
Anesthesia was induced with propofol (2mg/kg) and atracurium (0.5 mg/kg) after a sufficient relaxation based on (TOF = 0) the patients airway patency was maintained by a Classic Laryngeal Mask Airway
Category
Other
2
Description
Pre induction hydration was done with 7 mL/kg Ringer solution in all patients. Premedication was provided by intravenous midazolam (0.05 mg/kg) and fentanyl (2mcg/kg).
Anesthesia was induced with propofol (2mg/kg) and atracurium (0.5 mg/kg) after a sufficient relaxation based on (TOF = 0) the patients airway patency was maintained by a Supreme Laryngeal Mask Airway.
Category
Other
3
Description
Pre induction hydration was done with 7 mL/kg Ringer solution in all patients. Premedication was provided by intravenous midazolam (0.05 mg/kg) and fentanyl (2mcg/kg).
Anesthesia was induced with propofol (2mg/kg) and atracurium (0.5 mg/kg) after a sufficient relaxation based on (TOF = 0) the patients airway patency was maintained by laryngoscopy and tracheal intubation.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi Hospital
Full name of responsible person
Fereydoon Fekrat
Street address
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Abdulazim Nejatizadeh
Street address
Joomhoori Islami Blv.Deputy of Research Center,Shahid Mohammadi Hospital, Bandar Abbas, Iran.
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
HUMS
Full name of responsible person
Fereydoon Fekrat
Position
specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Shahid Mohamadi Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 1334 7002
Fax
Email
fereydoonfekrat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
HUMS
Full name of responsible person
Fereydoon Fekrat
Position
specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Shahid Mohamadi Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 1334 7002
Fax
Email
fereydoonfekrat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
HUMS
Full name of responsible person
Fereydoon Fekrat
Position
specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Shahid Mohamadi Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 1334 7002
Fax
Email
fereydoonfekrat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)