Comparison of Hemodynamic Signs and Level of Abdominal Pain in Using High and Low Pressures of Carbon Dioxide Gas in Patients Undergo Laparoscopic Cholecystectomy
Objectives:
The aim of this study is to compare of the effects of using two different pressures of carbon dioxide gas in patients who undergo laparoscopic cholecystectomy.
Design:
In this clinical trial, 60 patients aged 20-70 years who are candidate for laparoscopic cholecystectomy will be randomly divided into two groups. For the first group carbon dioxide pressure will be 7-10 mmhg (low pressure) and for the second group it will be 12-14 mmhg (high pressure). Each group consists of 30 patients.
Setting and conduct:
The general anesthesia protocol and surgical method are the same in both groups. Two surgeons with similar resume will perform the operations using the standard 4-port laparoscopic cholecystectomy. The only difference between the groups is the pressure of CO2 gas.
Major Inclusion and Exclusion criteria:
Patients who are candidate for laparoscopic cholecystectomy without ruptured gallbladder or empyema.
Intervention:
Usage of CO2 gas with low or high pressure during the operation.
Main outcome measures (variables):
Hemodynamic signs, nausea and vomiting and abdominal and shoulder pain will be measured at 1, 3, 6, 12 and 24 hours after the surgery and mean liver tests before and after the operation will be assessed in patients of the two groups.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014121420309N1
Registration date:2015-01-26, 1393/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-26, 1393/11/06
Registrant information
Name
Fereshteh Esmaili
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
f.esmaeili@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Qazvin University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Hemodynamic Signs and Level of Abdominal Pain in Using High and Low Pressures of Carbon Dioxide Gas in Patients Undergo Laparoscopic Cholecystectomy
Public title
Evaluating Intra-abdominal Gas related Symptoms During Cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20-70 years who are candidate for laparoscopic cholecystectomy
Exclusion criteria:
Rupture of the gallbladder, empyema, common bile duct stones, history of major upper abdominal surgeries, pregnancy, patients with a BMI (Body Mass Index) greater than 30 or less than 19, fatty liver grade 3 or 4, abnormalities of liver enzymes before surgery
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the present study patients will be randomly divided into two groups with the usage of randomized block design. During the surgery and after that, the patients and the surgeons won't be aware of the used carbon dioxide pressure for the laparoscopy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
28.20.8501
Health conditions studied
1
Description of health condition studied
Cholecystectomy (Laparoscopic)
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract
2
Description of health condition studied
Disorders related to gallbladder and bile ducts
ICD-10 code
K87.0
ICD-10 code description
Disorders of gallbladder and biliary tract in diseases classified elsewhere
Primary outcomes
1
Description
Mean arterial blood pressure
Timepoint
At admission, during the operation, 1, 3 and 6 hours after the surgery
Method of measurement
Monitoring
2
Description
Heart rate
Timepoint
At admission, during the operation, 1, 3 and 6 hours after the surgery
Method of measurement
Monitoring
3
Description
Body Temperature
Timepoint
At admission, during the operation, 1, 3 and 6 hours after the surgery
Method of measurement
Thermometer
Secondary outcomes
1
Description
Nausea & vomiting after Laparoscopic Cholecystectomy
Timepoint
1, 3, 6, 12 and 24 hours after the operation
Method of measurement
Verbal Rating Scale Questionnaire
2
Description
Abdominal and shoulder pain after Laparoscopic Cholecystectomy
Timepoint
1, 3, 6, 12 and 24 hours after the operation
Method of measurement
Verbal Rating Scale Questionnaire
3
Description
Liver Tests
Timepoint
Before and after the operation
Method of measurement
Laboratory Data
Intervention groups
1
Description
First intervention group (low pressure):
Usage of carbon dioxide gas with percent purity of 99% from Qazvin Oxygen Company, gas pressure: 7-10 mmhg
Category
Prevention
2
Description
Second intervention group (high pressure):
Usage of carbon dioxide gas with percent purity of 99% from Qazvin Oxygen Company, gas pressure: 12-14 mmhg
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat General Hospital
Full name of responsible person
Doctor Fereshteh Esmaili
Street address
Taavon Square
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Boulevard
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Doctor Fereshteh Esmaili
Position
Resident of General Surgery
Other areas of specialty/work
Street address
General Velayat Hospital, Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
dr.esmaili83@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Doctor Alireza Mohammadzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
General Velayat Hospital, Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
dr.esmaili83@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Doctor Fereshteh Esmaili
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Velayat Hospital, Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
dr.esmaili83@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)