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Trial record 39 of 680 for:    CARBON DIOXIDE AND arterial

Arterial Blood Gas Analysis in Laparoscopic Cholecystectomy (ABG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03133494
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Amiya Kumar Barik, Banaras Hindu University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cholecystectomy, Laparoscopic Other: ABG analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arterial blood gas sample was drawn from both the groups and analysed for any change in the desired parameters
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: Comparing Arterial Blood Gas(ABG) in Laparoscopic Cholecystectomy Between Smokers and Non Smokers: A Randomized Double Blind Case Control Study
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : April 1, 2016
Actual Study Completion Date : April 1, 2016

Arm Intervention/treatment
Active Comparator: Laparoscopic cholecystectomy in smokers
ABG analysis of patients with history of smoking posted for laparoscopic cholecystectomy was collected
Other: ABG analysis
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
Other: ABG analysis
ABG analysis was performed and compared between two groups




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133494


Sponsors and Collaborators
Banaras Hindu University
Investigators
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Principal Investigator: PUSKAR RANJAN, MD, PhD Banaras Hindu University

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Responsible Party: Amiya Kumar Barik, abarik, Final year resident, Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT03133494    
Other Study ID Numbers: 2014-15/EC/1219
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No