此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients

2026年6月18日 更新者:Gaziantep City Hospital

Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery

Obese patients are at increased risk of postoperative cognitive dysfunction (POCD). The effects of different anesthetic techniques on postoperative cognitive function remain controversial. This prospective randomized study aimed to compare the effects of low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, and total intravenous anesthesia (TIVA) on postoperative cognitive function and recovery characteristics in obese patients undergoing elective laparoscopic abdominal surgery. Cognitive function was assessed using the Mini-Mental State Examination (MMSE) before surgery, at postoperative 30 minutes, and on postoperative day 3.

研究概览

详细说明

Obesity is associated with physiological alterations that may increase the risk of postoperative cognitive dysfunction (POCD). The influence of anesthetic techniques on postoperative cognitive outcomes in obese patients remains uncertain.

This prospective randomized study was conducted in obese patients (BMI ≥30 kg/m²) aged 18-65 years undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients were randomly assigned to one of three groups: low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, or total intravenous anesthesia (TIVA). Anesthetic depth was monitored using bispectral index (BIS) monitoring and maintained between 40 and 60 in all groups.

The primary objective was to compare postoperative cognitive function among the three anesthetic techniques using the Mini-Mental State Examination (MMSE). MMSE scores were evaluated preoperatively, at postoperative 30 minutes, and on postoperative day 3.

Secondary objectives included comparison of recovery characteristics, including eye-opening time, extubation time, Modified Aldrete Recovery Scores, and perioperative hemodynamic parameters.

The study was approved by the Marmara University Faculty of Medicine Clinical Research Ethics Committee (Approval No. 09.2022.744) and written informed consent was obtained from all participants before enrollment.

研究类型

介入性

注册 (实际的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Istanbul
      • Istanbul、Istanbul、土耳其(türkiye)、34899
        • Marmara University Faculty of Medicine Pendik Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥30 kg/m²
  • ASA physical status I-III
  • Scheduled for elective laparoscopic abdominal surgery
  • Provision of written informed consent

Exclusion Criteria:

  • History of psychiatric disease
  • Dementia or known cognitive impairment
  • Hearing or language disorders preventing MMSE assessment
  • Refusal to participate
  • Conversion from laparoscopic to open surgery

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Low-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 1 L/min during maintenance of anesthesia. Anesthetic depth was maintained with BIS values between 40 and 60.
Maintenance of general anesthesia with sevoflurane inhalation. Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
实验性的:Normal-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 3 L/min during maintenance of anesthesia. Anesthetic depth was maintained with BIS values between 40 and 60.
Maintenance of general anesthesia with sevoflurane inhalation. Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
实验性的:Total Intravenous Anesthesia (TIVA)
Patients received total intravenous anesthesia with propofol and remifentanil infusion. Anesthetic depth was maintained with BIS values between 40 and 60.
Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mini-Mental State Examination (MMSE) Score
大体时间:Preoperative, postoperative 30 minutes, and postoperative day 3
Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).
Preoperative, postoperative 30 minutes, and postoperative day 3

次要结果测量

结果测量
措施说明
大体时间
Eye Opening Time
大体时间:End of surgery
Time from discontinuation of anesthetic administration to spontaneous eye opening
End of surgery
Extubation Time
大体时间:End of surgery
Time from discontinuation of anesthetic administration to tracheal extubation.
End of surgery
Modified Aldrete Recovery Score
大体时间:Postoperative recovery period
Recovery status assessed using the Modified Aldrete Score.
Postoperative recovery period
heart rate
大体时间:During surgery
patient's intraoperative measured heart rate
During surgery
mean arterial pressure
大体时间:during surgery
patient's intraoperative measured mean arterial pressure
during surgery
oxygen saturation
大体时间:During surgery
oxygen saturation of the patient will be recorded
During surgery
end-tidal carbon dioxide
大体时间:During surgery
end-tidal carbon dioxide of the patient will be recorded
During surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ahmet Tunca, MD、Department of Anesthesiology and Reanimation, Gaziantep City Hospital
  • 学习椅:Seniyye Ü Zengin, MD、Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
  • 研究主任:Meliha O Ergün, MD、Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年1月10日

初级完成 (实际的)

2023年6月20日

研究完成 (实际的)

2023年6月20日

研究注册日期

首次提交

2026年6月13日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月18日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be made publicly available due to privacy and confidentiality considerations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅