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临床试验/NCT07491185
NCT07491185招募中不适用

Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study

Ege University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Change in Regional Cerebral Oxygen Saturation (rSO2)

研究概览

简要总结

This prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia.

Patients will be grouped according to HbA1c levels to assess the relationship between long-term glycemic control and intraoperative regional cerebral oxygen saturation, hemodynamic parameters, and postoperative recovery scores.

详细描述

Diabetes mellitus is associated with increased perioperative morbidity and mortality, particularly in patients with poor long-term glycemic control. Elevated HbA1c levels may impair microcirculation and tissue oxygenation, which can affect cerebral perfusion during general anesthesia. Near-infrared spectroscopy (NIRS) is a non-invasive monitoring technique that allows continuous measurement of regional cerebral oxygen saturation and may help detect intraoperative hypoperfusion.

This prospective observational study is designed to investigate the relationship between glycemic control level and intraoperative cerebral oxygenation as well as postoperative recovery parameters in patients undergoing elective urologic surgery under general anesthesia. Patients will be divided into four groups according to preoperative HbA1c levels, including non-diabetic patients and diabetic patients with different levels of glycemic control.

Intraoperative monitoring will include standard hemodynamic parameters and bilateral regional cerebral oxygen saturation measured with near-infrared spectroscopy. The primary objective of the study is to determine whether poor glycemic control is associated with impaired cerebral oxygenation during anesthesia. Secondary objectives include evaluation of postoperative recovery parameters in relation to glycemic control level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥18 years
  • Patients scheduled for elective urologic surgery under general anesthesia
  • ASA physical status I-III
  • Patients with diabetes mellitus or non-diabetic control patients
  • Availability of preoperative HbA1c measurement
  • Written informed consent obtained

排除标准

  • Age <18 years
  • ASA physical status >III
  • Emergency surgery
  • History of cerebrovascular disease or neurological disorder
  • Previous brain or neurological surgery
  • Inability to communicate or refusal to participate
  • Intraoperative hemodynamic instability
  • Inadequate NIRS monitoring data

结局指标

主要结局

Change in Regional Cerebral Oxygen Saturation (rSO2)

时间窗: Intraoperative period (from anesthesia induction to extubation)

Regional cerebral oxygen saturation measured intraoperatively using near-infrared spectroscopy and compared between groups according to HbA1c level.

次要结局

未报告次要终点

研究者

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

Nursen Karaca

MD

Ege University

研究点 (1)

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