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临床试验/NCT05992636
NCT05992636已完成不适用

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

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
the relationship between insufflation flow rate and cerebral desaturation (rSO2)

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

the relationship between insufflation flow rate and cerebral desaturation (rSO2)

时间窗: 8 months

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 )

次要结局

  • the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)(8 months)
  • the relationship between insufflation flow rate and heart rate value variation (beats per minute)(8 months)
  • the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)(8 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SEDAT SAYLAN

Associate Prof.

Karadeniz Technical University

研究点 (1)

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