Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy

The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy

Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum
• Intervention / Treatment: Procedure: pneumoperitoneum insufflation (flow) rate

Detailed Description

After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and high insufflation flow (40 lt/min) with pneumoperitoneum pressure.

The study will be conducted as a single-center observational study in Trabzon KTU Faculty of Medicine General Surgery Operating Room. Anesthesia always be performed by the same anesthesia team, and no intervention will be made regarding the choice of the method. The data obtained will be recorded by the anesthetists other than the team who constitute the study group, and the data obtained at the end of the surgery will be interpreted by the study team. The decision for laparoscopic cholecystectomy of the patients who will be included in the study will be made by the General Surgery doctor, and the patients who are scheduled to be operated on electively will be included in the study.

The patients will be taken to the operating room after their written consents are obtained and preoperative evaluations are made, and routine premedication will be applied to the patients who arrive at the operating room. The patients who will be included in the study will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG), non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in which patients who will undergo general anesthesia will be in the pneumoperitoneum group formed with low insufflation flow or high insufflation flow, only non-invasive cerebral oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

After the approval of the Ethics Committee, a total of 69 (sixty) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients with low insufflation flow (10 lt/min), and 35 (thirty-five) patients in high insufflation flow (40 lt/min) with pneumoperitoneum pressure.

Description

Inclusion Criteria:

• elective laparoscopic cholecystectomy were planned,
• ASA I-III,
• 18-65 years old

Exclusion Criteria:

• Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
• Uncontrolled diabetes
• Uncontrolled hypertension
• Coagulopathy,
• Cirrhosis and/or peritonitis,
• Asthma and/or respiratory diseases e.g. COPD,
• Morbid obesity,
• Patients with severe organ failure,
• Emergency cases,
• Cases converted to laparotomic cholecystectomy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low insufflation flow (10 lt/min); Patiens who perform pneumoperitoneum with low insufflation flow (10 lt/min)	Procedure: pneumoperitoneum insufflation (flow) rate; Patiens who initiate with low insufflation flow (10 lt/min) Patiens who initiate with high insufflation flow (40 lt/min)
high insufflation flow (40 lt/min); Patiens who perform pneumoperitoneum with high insufflation flow (40 lt/min)	Procedure: pneumoperitoneum insufflation (flow) rate; Patiens who initiate with low insufflation flow (10 lt/min) Patiens who initiate with high insufflation flow (40 lt/min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the relationship between insufflation flow rate and cerebral desaturation (rSO2)	With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS). The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)	Relationship between insufflation flow rate and end-tidal carbon dioxide value variation of the patients according to basal and before-pnömoperitoneum end-tidal carbon dioxide levels (mmHg) was determined with capnographic measurements.	8 months
the relationship between insufflation flow rate and heart rate value variation (beats per minute)	Relationship between insufflation flow rate and heart rate value variation of the patients according to basal and before-pnömoperitoneum heart rate levels was determined with pulse monitoring.	8 months
the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)	Relationship between insufflation flow rate and systolic, diastolic and mean arterial pressure (mmHg) values variation of the patients according to basal and before-pnömoperitoneum systolic, diastolic and mean arterial pressure levels were determined with non-invasive blood pressure measurements.	8 months

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Study Chair: KIVANÇ ÖNCÜ, M.D., Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): April 23, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; Near Infrared Spectroscopy (NIRS)
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: Karadeniz Teknik Üniversitesi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes