We aimed to compare hemodynamic and endocrine alterations caused by stress response due to Proseal laryngeal mask airway and endotracheal tube usage in laparoscopic cholecystectomy in this randomized double blinded trial.
Sixty-three ASA I-II patients scheduled for elective laparoscopic cholecystectomy were included in the study. Patients were randomly allocated into two groups of endotracheal tube and Proseal laryngeal mask airway. Standard general anaesthesia was performed in both groups with the same drugs in induction and maintenance of anaesthesia. After anaesthesia induction and 20 minutes after CO2 insufflations, venous blood samples were obtained for measuring adrenalin, noradrenalin, dopamine and cortisol levels. Hemodynamic and respiratory parameters were recorded at the 1st, 5th, 15th, 30th and 45th minutes after the insertion of airway devices.
General information
Acronym
Stress response caused by airway devices
IRCT registration information
IRCT registration number:IRCT201202128979N1
Registration date:2012-03-09, 1390/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-09, 1390/12/19
Registrant information
Name
türkay çakan
Name of organization / entity
Ministry of health ankara training and research hospital
Country
Turkey
Phone
+90 312 5953175
Email address
turkaycakan@yahoo.com
Recruitment status
Recruitment complete
Funding source
No funding source
Expected recruitment start date
2008-03-01, 1386/12/11
Expected recruitment end date
2008-06-30, 1387/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic and metabolic stress responses caused by endotracheal tube and Proseal laryngeal mask airway in laparoscopic cholecystectomy
Public title
Two different airway device in laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
ASA I-II patients, aged between 20-70 years scheduled for elective laparoscopic cholecystectomy, were included in the study/. Exclusion criteria were a known or predicted difficult airway, hypertension, diabetes mellitus, chronic obstructive pulmonary disease, cardiac disease, history of allergic reaction, history of corticosteroid drug usage, and body mass index greater than 35 kg/m2.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No other desing features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ministry of health ankara training and research hospital local ethics committee
Street address
ulucanlar caddesi
City
Altındağ
Postal code
Approval date
2008-03-26, 1387/01/07
Ethics committee reference number
2031
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K80-K87
ICD-10 code description
calculus of gallbladderwith other cholecystitis
Primary outcomes
1
Description
Heart rate and mean arterial blood pressure(MAP)
Timepoint
1.,5.,15.,30. and 45. minutes after insertion of airway devices.25%increase or decrease in MAP and hearth rate >120beat/minute or <50 beat/minute.
Method of measurement
ECG and non-invasive blood pressure measurement
Secondary outcomes
1
Description
Adrenalin,noradrenalin,dopamine and cortisol
Timepoint
After induction of anesthesia and 20 minutes after CO2 insufflation
Method of measurement
High pressure liquid chromatographyfor were used for measuring adrenalin,noradrenalin and dopamineand modular AnaliticE 170 module was used for measuring cortsol
Intervention groups
1
Description
Endotracheal tube
Category
Treatment - Surgery
2
Description
proseal laryngeal mask usage
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ministry of health Ankara Training and Research Hospital
Full name of responsible person
Türkay Çakan
Street address
Ulucanlar caddesi
City
Altındağ
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PI initiated
Full name of responsible person
No sponsor
Street address
No sponsor
City
no sponsor
Grant name
Grant code / Reference number
No code
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PI initiated
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
Associate professor in Anesthesiology ankara training and research hospital
Full name of responsible person
Hülya Başar
Position
Chief of department of anesthesiology
Other areas of specialty/work
Street address
ulucanlar caddesi
City
Altındağ
Province
Ankara
Postal code
Phone
0090 312 5953180
Fax
Email
hulya_basar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Associate professor in Anesthesiology in ankara training and research hospital
Full name of responsible person
Hülya Başar
Position
Chief of department of anesthesiology
Other areas of specialty/work
Street address
Ulucanlar caddesi
City
Altındağ
Province
Ankara
Postal code
Phone
00903125953180
Fax
Email
hulya_basar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ministry of health Ankara Training and Research Hospital
Full name of responsible person
Türkay Çakan
Position
Specialist in Anesthesiology
Other areas of specialty/work
Street address
Ulucanlar caddesi
City
Altındağ
Province
Ankara
Postal code
Phone
00903125953175
Fax
Email
turkaycakan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)