ABG: Arterial Blood Gas Analysis in Laparoscopic Cholecystectomy

Sponsor

Banaras Hindu University (Other)

Overall Status

Completed

CT.gov ID

NCT03133494

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 parametersArterial 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 :

Apr 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Arterial blood gas parameter like potential of hydrogen (PH) [10 minutes before starting to 30 minutes after completion of surgery]
Above parameter was measured by serial ABG analysis

Secondary Outcome Measures

Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2) [10 minutes before starting to 30 minutes after completion of surgery]
Above parameter was measured by serial ABG analysis
Arterial blood gas parameter like bicarbonate(HCO3) [10 minutes before starting to 30 minutes after completion of surgery]
Above parameter was measured by serial ABG analysis
Arterial blood gas parameter like base excess (BE) [10 minutes before starting to 30 minutes after completion of surgery]
Above parameter was measured by serial ABG analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Banaras Hindu University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 28, 2017

Last Update Posted:

May 17, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2017