PneumoperitoneumNCT04309318
Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressure Ranges (10-12 mmHg and 13- 15 mmHg ) on Cerebral Oxygenation (With a Non-invasive Technique, Near Infrared Spectroscopy (NIRS) ) in Laparoscopic Cholecystectomy
An observational study of Pneumoperitoneum, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- Low pneumoperitoneum (10-12 mmHg) pressure range group and High pneumoperitoneum (13-15 mmHg) pressure range group
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 30 Jun 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective laparoscopic cholecystectomy between February 2020 and September 2020 at Karadeniz Technical University Faculty of Medicine Farabi Hospital under specified conditions
Who may be able to join
- American Society of Anaesthesiology (ASA) I-III,
- 18-65 years old
- under general anesthesia
- elective laparoscopic cholecystectomy
Who cannot join
- cerebrovascular diseases
- uncontrolled diabetes
- uncontrolled hypertension
- coagulopathy
- cirrhosis
- peritonitis
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- asthma
- respiratory diseases such as chronic obstructive pulmonary disease (COPD)
- patients with morbid obesity
- multiple organ failure
- cases taken under emergency conditions
- cases returned to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressures on Cerebral Oxygenation in Laparoscopic Cholecystectomy
The negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known.
Pneumoperitoneum formed with low (10 - 12 mmHg) intraabdominal pressure causes less fluctuations in hemodynamic and respiratory changes. Previous studies have shown that intraabdominal pressure increase is effective on cerebral metabolism, leading to increased intracranial pressure.
The aim of this study is to investigate the hemodynamic effects of two different pneumoperitoneum pressure ranges (10-12 mmHg and 13-15 mmHg) on cerebral oxygenation with using Near Infrared Spectroscopy (NIRS), which is is a non-invasive technique, in laparoscopic cholecystectomy surgeries.
Read the detailed description
The negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known.It is thought that pneumoperitoneum causes hemodynamic changes in the body by increasing blood catecholamine, vasopressin and norepinephrine levels.Sensitivity to these hemodynamic changes has been shown to be higher rate in patients with advanced age, morbid obesity, and increased intracranial pressure, and it is emphasized in studies that more attention should be paid to pneumoperitoneum pressures used in laparoscopic procedures with these groups.
In laparoscopic cholecystectomy surgery, pneumoperitoneum pressures used for surgical field visualization may differ.As a consequences, these different pressures have different haemodynamic and intracranial effects.Studies have shown that high intraabdominal pressure values cause more hemodynamic fluctuations than low intraabdominal pressure values.Systemic side effects have been shown to be lower in operations with low pneumoperitoneum pressure; In relation to the concept of multiple compartment syndrome, it is thought that the relationships between intraabdominal, intrathoracic and intracranial compartments, and changes in one compartment may affect other compartments and cause negative physiological and hemodynamic results.
There are studies in the literature on the hemodynamic effects of different pneumoperitoneum pressures.In our literature searches, we could not find any study comparing the effects of hemodynamic changes caused by two different pneumoperitoneum pressures, which can be classified as low and high, on cerebral oxygenation.We aimed to contribute to the literature by investigating the effects of different pneumoperitoneum pressure ranges on brain oxygenation.
- Conditions
- Pneumoperitoneum
- Being tested
- Low pneumoperitoneum (10-12 mmHg) pressure range group, High pneumoperitoneum (13-15 mmHg) pressure range group
- Keywords
- laparoscopic cholecystectomy, Pneumoperitoneum, Near Infrared Spectroscopy (NIRS)
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pneumoperitoneum (10-12 mmHg) pressure range groupProcedure or surgery
Patients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure
High pneumoperitoneum (13-15 mmHg) pressure range groupProcedure or surgery
Patients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure
| Study group | Role | What they receive |
|---|---|---|
| Low pneumoperitoneum (10-12 mmHg) pressure range group | Patients who have elective laparoscopic cholecystectomy with 10-12 mmHg intra-abdominal pneumoperitoneum pressure Receives: Procedure: Low pneumoperitoneum (10-12 mmHg) pressure range group | |
| High pneumoperitoneum (13-15 mmHg) pressure range group | Patients who have elective laparoscopic cholecystectomy with 13-15 mmHg intra-abdominal pneumoperitoneum pressure Receives: Procedure: High pneumoperitoneum (13-15 mmHg) pressure range group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigating the corelation between pneumoperitoneum pressure(mmHg) and brain oxygenation (with numeric NIRS value)
Investigating the effects of different pneumoperitoneum pressure ranges (10-12 mmHg and 13-15 mmHg) on brain oxygenation with NIRS (according to baseline NIRS value )
Measured: February 2020 - February 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Feb 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDAT SAYLAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309318
- Sponsor's protocol ID
- 2020/11
- Status last verified
- Dec 2020
- First submitted
- 9 Mar 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressures on Cerebral Oxygenation in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04309318
- Acronym / sponsor ID
- 2020/11
- Conditions
- Pneumoperitoneum
- Keywords
- laparoscopic cholecystectomy, Pneumoperitoneum, Near Infrared Spectroscopy (NIRS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 16 Mar 2020 (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 negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known.
Pneumoperitoneum formed with low (10 - 12 mmHg) intraabdominal pressure causes less fluctuations in hemodynamic and respiratory changes. Previous studies have shown that intraabdominal pressure increase is effective on cerebral metabolism, leading to increased intracranial pressure.
The aim of this study is to investigate the hemodynamic effects of two different pneumoperitoneum pressure ranges (10-12 mmHg and 13-15 mmHg) on cerebral oxygenation with using Near Infrared Spectroscopy (NIRS), which is is a non-invasive technique, in laparoscopic cholecystectomy surgeries.
Detailed description
The negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known.It is thought that pneumoperitoneum causes hemodynamic changes in the body by increasing blood catecholamine, vasopressin and norepinephrine levels.Sensitivity to these hemodynamic changes has been shown to be higher rate in patients with advanced age, morbid obesity, and increased intracranial pressure, and it is emphasized in studies that more attention should be paid to pneumoperitoneum pressures used in laparoscopic procedures with these groups.
In laparoscopic cholecystectomy surgery, pneumoperitoneum pressures used for surgical field visualization may differ.As a consequences, these different pressures have different haemodynamic and intracranial effects.Studies have shown that high intraabdominal pressure values cause more hemodynamic fluctuations than low intraabdominal pressure values.Systemic side effects have been shown to be lower in operations with low pneumoperitoneum pressure; In relation to the concept of multiple compartment syndrome, it is thought that the relationships between intraabdominal, intrathoracic and intracranial compartments, and changes in one compartment may affect other compartments and cause negative physiological and hemodynamic results.
There are studies in the literature on the hemodynamic effects of different pneumoperitoneum pressures.In our literature searches, we could not find any study comparing the effects of hemodynamic changes caused by two different pneumoperitoneum pressures, which can be classified as low and high, on cerebral oxygenation.We aimed to contribute to the literature by investigating the effects of different pneumoperitoneum pressure ranges on brain oxygenation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pneumoperitoneum (10-12 mmHg) pressure range group | – | Procedure: Low pneumoperitoneum (10-12 mmHg) pressure range groupPatients who have elective laparoscopic cholecystectomy with 10-12 mmHg intra-abdominal pneumoperitoneum pressure |
| High pneumoperitoneum (13-15 mmHg) pressure range group | – | Procedure: High pneumoperitoneum (13-15 mmHg) pressure range groupPatients who have elective laparoscopic cholecystectomy with 13-15 mmHg intra-abdominal pneumoperitoneum pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective laparoscopic cholecystectomy between February 2020 and September 2020 at Karadeniz Technical University Faculty of Medicine Farabi Hospital under specified conditions
Key inclusion criteria (4 listed)
- American Society of Anaesthesiology (ASA) I-III,
- 18-65 years old
- under general anesthesia
- elective laparoscopic cholecystectomy
Key exclusion criteria (12 listed)
- cerebrovascular diseases
- uncontrolled diabetes
- uncontrolled hypertension
- coagulopathy
- cirrhosis
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 |
|---|---|---|
| Low pneumoperitoneum (10-12 mmHg) pressure range groupPatients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure | Procedure or surgery | Low pneumoperitoneum (10-12 mmHg) pressure range group |
| High pneumoperitoneum (13-15 mmHg) pressure range groupPatients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure | Procedure or surgery | High pneumoperitoneum (13-15 mmHg) pressure range group |
Primary outcome
Investigating the corelation between pneumoperitoneum pressure(mmHg) and brain oxygenation (with numeric NIRS value)
Time frame: February 2020 - February 2021
Investigating the effects of different pneumoperitoneum pressure ranges (10-12 mmHg and 13-15 mmHg) on brain oxygenation with NIRS (according to baseline NIRS value )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Investigating the corelation between pneumoperitoneum pressure(mmHg) and brain oxygenation (with numeric NIRS value) (time frame: February 2020 - February 2021). 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 29 Dec 2020.