Clinical trial NCT05992636: Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
Official title: The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumoperitoneum
Keywords: laparoscopic cholecystectomy
Near Infrared Spectroscopy (NIRS)
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: the relationship between insufflation flow rate and cerebral desaturation (rSO2)
timeFrame: 8 months
Secondary outcomes:
measure: the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)
timeFrame: 8 months
measure: the relationship between insufflation flow rate and heart rate value variation (beats per minute)
timeFrame: 8 months
measure: the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)
timeFrame: 8 months
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: KIVANÇ ÖNCÜ, M.D.
role: STUDY_CHAIR
References: