Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy

Pneumoperitoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05992636
• Other study ID #: Karadeniz Teknik Üniversitesi
• Status: Completed
• Start date: May 19, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: August 2023
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 20, 2022
• Est. primary completion date: April 23, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumoperitoneum

Intervention

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)

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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