Arterial Blood Gas Analysis in Laparoscopic Cholecystectomy (ABG)

May 15, 2017 updated by: Amiya Kumar Barik, Banaras Hindu University

Comparing Arterial Blood Gas(ABG) in Laparoscopic Cholecystectomy Between Smokers and Non Smokers: A Randomized Double Blind Case Control Study

The investigator found out that as such the base line carbon dioxide (CO2) level is higher in smokers as compared to non-smokers even before creation of pneumoperitoneum, which is due to the compromised lung function following chronic smoking. This condition gets aggravated after creation of pneumoperitoneum which is very much evident from the serial arterial blood gas analysis. The level of CO2 remains elevated even after deflation of the pneumoperitoneum. Hence one has to be very much vigilant not only during intra-operative period but also in post-operative care unit. Hence serial ABG monitoring should be included as a part of the protocol especially in laparoscopic surgeries.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: PUSKAR RANJAN, MD, PhD, Banaras Hindu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 12, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Cholecystectomy, Laparoscopic

Clinical Trials on ABG analysis

Subscribe