The present study aims to compare the effect of general and epidural anesthesia on respiratory parameters during and after laparoscopic cholecystectomy surgery. Samples include all patients receiving laparoscopic cholecystectomy surgery in Imam Reza University. It is a double-blind clinical trial. 58 patients are selected among all patients receiving laparoscopic cholecystectomy surgery, and are divided to two groups randomly, a group receiving general and the other receiving epidural anesthesia. After pre-medication among GA with midazolam 05.0 mg/kg, intravenous fentalyn 1 µg/kg, patients are anesthetized using propofol 2 mg/kg and atracurium 5.0 mg/kg and standard monitoring is completed. Proper indotratracheal tube is contrived and surgery starts. During the surgery, anesthetization continues through using isoflurane 1.4 1% blended with a mixture of air and 50% oxygen. Epidural set is used to inject 10 cc Lidocaine and epinephrine 1 in 200000, including 1 cc sodium bicarnonate in the space between vertebrae of the thoracic among EA group. ABG is tested during and after surgery and VC and SPO2 is measure through monitoring. Two groups are compared later. Entrance criteria includes written consent by patients; I, II ASA class; age range of 20 to 60; no history on respiratory or cardio problems; no history on diabetes or similar diseases needing treatment. Exclusion criterion is a surgery lasting more than 45 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081714333N19
Registration date:2014-09-07, 1393/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-07, 1393/06/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-06-15, 1393/03/25
Expected recruitment end date
2014-09-16, 1393/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of general and epidural anesthesia on respiratory parameters during and after laparoscopic cholecystectomy surgery
Public title
The effect of general and epidural anesthesia on respiratory parameters during and after laparoscopic cholecystectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Entrance criteria includes written consent by patients; I, II ASA class; age range of 20 to 60; no history on respiratory or cardio problems; no history on diabetes or similar diseases needing treatment. Exclusion criterion is a surgery lasting more than 45 minutes.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
10218/پ/420/7
Health conditions studied
1
Description of health condition studied
Laparascopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Cholecystolithiasis
Primary outcomes
1
Description
FEV1
Timepoint
A day before and after surgery
Method of measurement
Using spirometry
2
Description
VC
Timepoint
During and an hour after surgery
Method of measurement
Using anesthesia machine monitor
3
Description
SPO2
Timepoint
Before, during and an hour after surgery
Method of measurement
Using pulse oxy meter monitor
4
Description
PH
Timepoint
Before, during and an hour after surgery
Method of measurement
Using blood gas analysis (ABG)
5
Description
Pao2
Timepoint
Before, during and an hour after surgery
Method of measurement
Using blood gas analysis (ABG)
6
Description
PaCo2
Timepoint
Before, during and an hour after surgery
Method of measurement
Using blood gas analysis (ABG)
7
Description
Hco3
Timepoint
Before, during and an hour after surgery
Method of measurement
Using blood gas analysis (ABG)
8
Description
FVC
Timepoint
A day before and after surgery
Method of measurement
Through spirometry
9
Description
O2SAT
Timepoint
Before, during and an hour after surgery
Method of measurement
Using blood gas analysis (ABG)
Secondary outcomes
empty
Intervention groups
1
Description
In the first group(GA), After pre-medication among GA with midazolam 05.0 mg/kg, intravenous fentalyn 1 µg/kg, patients are anesthetized using propofol 2 mg/kg and atracurium 5.0 mg/kg and standard monitoring is completed. Proper indotratracheal tube is contrived and surgery starts. During the surgery, anesthetization continues through using isoflurane 1.4 1% blended with mixture of air and 50% oxygen. During the surgery ABG is tested and SPO2 is measured accordingly. An hour later, during recovery period, ABG is retested and VC and SPO2 are measured through monitoring.
Category
Treatment - Surgery
2
Description
In the second group (EA), 10 cc Lidocaine and epinephrine 1 in 200000, including 1 cc sodium bicarnonate for each 10 cc of Lidocaine, would be injected in the space between vertebrae of the thoracic using epidural set. ABG and SPO2 would be measured during surgery. ABG would be measured again, and VC and SPO2 would be checked using monitor an hour after surgery during recovery period.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr.iraj Peiman
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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 Affairs, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ali karbasforushan
Position
Anesthesiologist
Other areas of specialty/work
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
ali_karbasfrushan@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)