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
NCT ID: NCT04309318
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2020-02-01
2021-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Low pneumoperitoneum (10-12 mmHg) pressure range group
Patients who have elective laparoscopic cholecystectomy with 10-12 mmHg intra-abdominal pneumoperitoneum pressure
Low pneumoperitoneum (10-12 mmHg) pressure range group
Patients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure
High pneumoperitoneum (13-15 mmHg) pressure range group
Patients who have elective laparoscopic cholecystectomy with 13-15 mmHg intra-abdominal pneumoperitoneum pressure
High pneumoperitoneum (13-15 mmHg) pressure range group
Patients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure
Interventions
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Low pneumoperitoneum (10-12 mmHg) pressure range group
Patients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure
High pneumoperitoneum (13-15 mmHg) pressure range group
Patients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure
Eligibility Criteria
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Inclusion Criteria
* 18-65 years old
* under general anesthesia
* elective laparoscopic cholecystectomy
Exclusion Criteria
* uncontrolled diabetes
* uncontrolled hypertension
* coagulopathy
* cirrhosis
* peritonitis
* 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
18 Years
65 Years
ALL
No
Sponsors
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Karadeniz Technical University
OTHER
Responsible Party
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SEDAT SAYLAN
Assistant Professor
Locations
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Karadeniz Technical University
Trabzon, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020/11
Identifier Type: -
Identifier Source: org_study_id