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

NCT04309318 | Unknown FDA Device

• 1 other identifier: 2020/11
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pneumoperitoneum

Keywords

laparoscopic cholecystectomy; Pneumoperitoneum; Near Infrared Spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

• 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 )

  February 2020 - February 2021

Study Arms (2)

Low pneumoperitoneum (10-12 mmHg) pressure range group

Patients who have elective laparoscopic cholecystectomy with 10-12 mmHg intra-abdominal pneumoperitoneum pressure

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

Procedure: High pneumoperitoneum (13-15 mmHg) pressure range group

Interventions

Low pneumoperitoneum (10-12 mmHg) pressure range group PROCEDURE

Patients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure

Low pneumoperitoneum (10-12 mmHg) pressure range group

High pneumoperitoneum (13-15 mmHg) pressure range group PROCEDURE

Patients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure

High pneumoperitoneum (13-15 mmHg) pressure range group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• American Society of Anaesthesiology (ASA) I-III,
• years old
• under general anesthesia
• elective laparoscopic cholecystectomy

You may not qualify if:

• cerebrovascular diseases
• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: February 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)