Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG Monitoring (TandRT)
Recovery, Analgesia And Delirium Profiles At Laparoscopic Surgeries With Processed EEG Monitoring: Comparison Of Trendelenburg And Reverse-Trendelenburg Positions
The aim of this study is to evaluate the effects of processed electroencephalogram (pEEG) monitoring on recovery and extubation times, length of stay in the post-anesthesia care unit (PACU), postoperative pain, patient comfort, sedation, development of delirium, and length of hospital and intensive care unit stay in laparoscopic surgeries performed in the Trendelenburg (T) or reverse Trendelenburg (RT) positions.
Materials and Methods: This prospective, randomized, single-center study included a total of 136 patients will be scheduled for elective laparoscopic surgery under general anesthesia. Patients will allocated into four groups according to surgical position (Group T or Group RT) and the use of processed electroencephalogram monitoring (Group TBIS and Group RTBIS). Intraoperative depth of anesthesia will be maintained either by titration guided by processed electroencephalogram indices or according to standard clinical parameters. Extubation time, recovery time, length of stay in the PACU, postoperative pain scores, patient comfort, level of sedation, incidence of delirium, and lengths of hospital and intensive care unit stay will be recorded.
研究概览
地位
详细说明
A total of 136 adult patients aged 18-75 yr, classified as American Society of Anesthesiologists (ASA) physical status I-II, and scheduled for elective laparoscopic abdominal surgery with an anticipated duration of at least 1 h will be included.
Patients will be excluded if they had a history of neuropsychiatric disorders, neuromuscular disease, severe cardiovascular or respiratory disease, upper respiratory tract infection within the preceding 14 days, body mass index (BMI) >40 kg m-², alcohol or substance abuse, previous bronchospasm, anticipated difficult tracheal intubation, previous tracheostomy, laryngeal disease or surgery, ASA physical status ≥III, or an actual surgical duration of less than 1 h.
Randomization and Study Groups
Patients will be randomly allocated to one of four study groups according to surgical position and use of processed electroencephalographic monitoring:
Group TBIS: Trendelenburg position with BIS monitoring. Group T: Trendelenburg position without BIS monitoring. Group RTBIS: Reverse Trendelenburg position with BIS monitoring. Group RT: Reverse Trendelenburg position without BIS monitoring. Computer-generated randomization was used for group allocation.
Haemodynamic and respiratory variables, including systolic and diastolic arterial pressure, SpO₂, ETCO₂, peak airway pressure, and BIS values, will be recorded before and after positioning in the Trendelenburg or reverse Trendelenburg position.
Demographic and perioperative data, including age, sex, height, weight, type of surgery, duration of surgery, and duration of anaesthesia, will be collected.
Extubation and recovery times, total desflurane consumption and cumulative EEG suppression time will be recorded for all patients.
PACU discharge time, pain intensity (VAS score), cumulative morphine consumption, additional analgesic (meperidine) requirements, patient comfort, and haemodynamic variables will be assessed at 15, 30, and 60 min after PACU admission.
Delirium screening will ve performed before induction of anaesthesia, at PACU admission, at PACU discharge, and twice daily thereafter (08:00 and 20:00) from postoperative day 1 through postoperative day 3, or until hospital discharge if discharge occurred earlier. Postoperative adverse events, including nausea and vomiting, respiratory depression, bradycardia, hypotension, hypertension, shivering, and urinary incontinence, will be recorded. Intensive care unit (ICU) admission, ICU length of stay, and total hospital length of stay will also be documented.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Hakkı NA Ünlügenç, professor
- 电话号码:+90 3223386742 +905336417891
- 邮箱:unlugenc@cu.edu.tr
研究联系人备份
- 姓名:Zuhal Ünlügenç, MD
- 电话号码:+905323960620
- 邮箱:zunlugenc@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- adult patients aged 18-75 yr, classified as American Society of Anesthesiologists (ASA) physical status I-II, and scheduled for elective laparoscopic abdominal surgery with an anticipated duration of at least 1 h
Exclusion Criteria:
- if they had a history of neuropsychiatric disorders, neuromuscular disease, severe cardiovascular or respiratory disease, upper respiratory tract infection within the preceding 14 days, body mass index (BMI) >40 kg m-², alcohol or substance abuse, previous bronchospasm, anticipated difficult tracheal intubation, previous tracheostomy, laryngeal disease or surgery, ASA physical status ≥III, or an actual surgical duration of less than 1 h
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Group TBIS
Trendelenburg position with BIS monitoring
|
Group TBIS: Trendelenburg position with BIS monitoring.
Group T: Trendelenburg position without BIS monitoring.
Group RTBIS: Reverse Trendelenburg position with BIS monitoring.
Group RT: Reverse Trendelenburg position without BIS monitoring.
|
|
无干预:Group T
Trendelenburg position without BIS monitoring
|
|
|
有源比较器:Group RTBIS
Reverse Trendelenburg position with BIS monitoring
|
Group TBIS: Trendelenburg position with BIS monitoring.
Group T: Trendelenburg position without BIS monitoring.
Group RTBIS: Reverse Trendelenburg position with BIS monitoring.
Group RT: Reverse Trendelenburg position without BIS monitoring.
|
|
无干预:Group RT
Reverse Trendelenburg position without BIS monitoring
|
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 |
|---|---|---|
|
Shorter recovery times following surgery
大体时间:From enrollment to the end of the study at 5 months
|
The primary hypothesis was that routine pEEG monitoring would be associated with shorter recovery times following surgery
|
From enrollment to the end of the study at 5 months
|
合作者和调查者
调查人员
- 研究主任:HAKKI NA UNLUGENC, Professör、Cukurova University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Decision Number: 157
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
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