Cholecystectomy, LaparoscopicABGNCT03133494
Arterial Blood Gas Analysis in Laparoscopic Cholecystectomy
A study testing ABG analysis in people with Cholecystectomy, Laparoscopic, run by Banaras Hindu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- ABG analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 1 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American society of Anesthesiology (ASA) grade 1 and 2
- History of smoking (more than 20 pack year) for more than 10years
Who cannot join
- Patients refusal
- ASA grade 3 and 4
- Other lung pathologies
- Other cardiac pathologies
- uncontrolled diabetes mellitus
- systemic infection
Show all 9Show fewer
- emergency operation
- history of malignancy
- history of alcohol or drug abuse
About this study
Official title: 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.
Read the 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.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- ABG analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABG analysisOther
ABG analysis was performed and compared between two groups
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy in smokers | Active comparator | ABG analysis of patients with history of smoking posted for laparoscopic cholecystectomy was collected Receives: Other: ABG analysis |
| Laparoscopic cholecystectomy nonsmokers | Placebo comparator | ABG analysis of patients without history of smoking posted for laparoscopic cholecystectomy was collected Receives: Other: ABG analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gas parameter like potential of hydrogen (PH)
Above parameter was measured by serial ABG analysis
Measured: 10 minutes before starting to 30 minutes after completion of surgery
Secondary outcomes (3)
Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
Above parameter was measured by serial ABG analysis
Measured: 10 minutes before starting to 30 minutes after completion of surgery
Arterial blood gas parameter like bicarbonate(HCO3)
Above parameter was measured by serial ABG analysis
Measured: 10 minutes before starting to 30 minutes after completion of surgery
Arterial blood gas parameter like base excess (BE)
Above parameter was measured by serial ABG analysis
Measured: 10 minutes before starting to 30 minutes after completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Apr 2015
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arterial blood gas sample was drawn from both the groups and analysed for any change in the desired parameters
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amiya Kumar Barik, Banaras Hindu University
- Investigators
- PUSKAR RANJAN, MD, PhD, Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133494
- Sponsor's protocol ID
- 2014-15/EC/1219
- Acronym
- ABG
- Status last verified
- May 2017
- First submitted
- 12 Mar 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Arterial Blood Gas(ABG) in Laparoscopic Cholecystectomy Between Smokers and Non Smokers: A Randomized Double Blind Case Control Study
- ClinicalTrials.gov ID
- NCT03133494
- Acronym / sponsor ID
- ABG / 2014-15/EC/1219
- Conditions
- Cholecystectomy, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Arterial blood gas sample was drawn from both the groups and analysed for any change in the desired parameters
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy in smokers | Active comparator | Other: ABG analysisABG analysis of patients with history of smoking posted for laparoscopic cholecystectomy was collected |
| Laparoscopic cholecystectomy nonsmokers | Placebo comparator | Other: ABG analysisABG analysis of patients without history of smoking posted for laparoscopic cholecystectomy was collected |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American society of Anesthesiology (ASA) grade 1 and 2
- History of smoking (more than 20 pack year) for more than 10years
Key exclusion criteria (9 listed)
- Patients refusal
- ASA grade 3 and 4
- Other lung pathologies
- Other cardiac pathologies
- uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABG analysisABG analysis was performed and compared between two groups | Other | Laparoscopic cholecystectomy in smokers, Laparoscopic cholecystectomy nonsmokers |
Primary outcome
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
3 secondary outcomes
Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
Time frame: 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
Arterial blood gas parameter like base excess (BE)
Time frame: 10 minutes before starting to 30 minutes after completion of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cholecystectomy, Laparoscopic
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PUSKAR RANJAN, MD, PhD principal investigator
Banaras Hindu University
Questions about this trial
What is this clinical trial studying?
A study testing ABG analysis in people with Cholecystectomy, Laparoscopic, run by Banaras Hindu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gas parameter like potential of hydrogen (PH) (time frame: 10 minutes before starting to 30 minutes after completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.