- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03133494
Arterial Blood Gas Analysis in Laparoscopic Cholecystectomy (ABG)
Comparing Arterial Blood Gas(ABG) in Laparoscopic Cholecystectomy Between Smokers and Non Smokers: A Randomized Double Blind Case Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic cholecystectomy procedure is the treatment of choice for cholelithiasis as it has several advantages like smaller and more cosmetic incision, reduced blood loss, less postoperative pain, reduced post-operative stay, low post-operative complications, and early mobilization. Although this type of surgery is minimally invasive in nature but creation of pneumoperitoneum and postural changes causes a number of physiological alterations. Carbon dioxide (CO2) is the most commonly used gas for this purpose because it does not support combustion, is cleared more rapidly than other gases, and is highly soluble in blood. However, the disadvantage of CO2 is that the absorption of CO2 can cause hypercapnia and respiratory acidosis. Hypercapnia activates the sympathetic nervous system leading to an increase in blood pressure, heart rate, arrhythmias and myocardial contractility as well as it also sensitizes myocardium to catecholamines. Increased IAP may compress venous vessels causing an initial increase in preload, followed by a sustained decrease in preload.
Tobacco smoking is an internationally accepted health hazard. The United nation (UN) health agency reports that about 4.9 million people die each year across the globe due to cigarette smoking. Chronic smoking (more than 20 pack year at least for 10 year) causes a number of pathological changes in respiratory system which includes inflammatory changes in lung parenchyma, imbalance between protease and anti-protease, oxidative stress, cilliary dysfunction, mucosal hyper secretion, airflow limitation and pulmonary hypertension.
Arterial blood gas analysis plays a very important role in assessing the acid-base status, adequacy of oxygenation and ventilation. It is very useful in management of critically ill patients and in patients with pulmonary disorders. It is also a standard part of work-up for the patients who present with unexplained hypoxemia and dyspnea. An ABG test uses blood drawn from an artery, where the oxygen and carbon dioxide levels can be measured before they enter body tissues.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American society of Anesthesiology (ASA) grade 1 and 2
- History of smoking (more than 20 pack year) for more than 10years
Exclusion Criteria:
- Patients refusal
- ASA grade 3 and 4
- Other lung pathologies
- Other cardiac pathologies
- uncontrolled diabetes mellitus
- systemic infection
- emergency operation
- history of malignancy
- history of alcohol or drug abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laparoscopic cholecystectomy in smokers
ABG analysis of patients with history of smoking posted for laparoscopic cholecystectomy was collected
|
ABG analysis was performed and compared between two groups
|
Placebo Comparator: Laparoscopic cholecystectomy nonsmokers
ABG analysis of patients without history of smoking posted for laparoscopic cholecystectomy was collected
|
ABG analysis was performed and compared between two groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial blood gas parameter like potential of hydrogen (PH)
Time Frame: 10 minutes before starting to 30 minutes after completion of surgery
|
Above parameter was measured by serial ABG analysis
|
10 minutes before starting to 30 minutes after completion of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
Time Frame: 10 minutes before starting to 30 minutes after completion of surgery
|
Above parameter was measured by serial ABG analysis
|
10 minutes before starting to 30 minutes after completion of surgery
|
Arterial blood gas parameter like bicarbonate(HCO3)
Time Frame: 10 minutes before starting to 30 minutes after completion of surgery
|
Above parameter was measured by serial ABG analysis
|
10 minutes before starting to 30 minutes after completion of surgery
|
Arterial blood gas parameter like base excess (BE)
Time Frame: 10 minutes before starting to 30 minutes after completion of surgery
|
Above parameter was measured by serial ABG analysis
|
10 minutes before starting to 30 minutes after completion of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: PUSKAR RANJAN, MD, PhD, Banaras Hindu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-15/EC/1219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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