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临床试验/NCT03016234
NCT03016234已完成不适用

Intraocular Pressure Changes During Laparoscopic Colorectal Surgery: Propofol Versus Desflurane Anesthesia

Saint Vincent's Hospital, Korea1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
changes in intraocular pressure (IOP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.

研究概览

简要总结

This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized controlled trial. The patients were randomly assigned to desflurane or propofol administrated groups and all patient are administered intravenous remifentanil continuously as adjuvant analgesics during anesthesia. For this study 50 to 80-year-old patients undergoing laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen® Avia tonometer) on both eyes were measured at defined intervals during the procedure.

详细描述

Perioperative visual loss is a rare but devastating complication associated with certain type of operative procedures. Laparoscopic or robotic surgeries for colorectal cancer, prostate cancer and diseases of the female genital organs in the pelvic cavity are performed in a steep Trendelenburg position and pneumoperitoneum, which increases the intraocular pressure (IOP) by 13-26 mmHg compared with the preoperative IOP value. High intraocular pressure is believed to correlate with decreased perfusion to the optic nerve, and thus could lead to ischemic optic neuropathy. The objective of the study is to test which anesthetic agent (desflurane or propofol) can attenuate the changes in IOP during laparoscopic colorectal surgery and identify correlated parameters. Fifty patients (30-80 years; American Society of Anesthesiologists' physical status 1-2) scheduled for laparoscopic colorectal surgery will be enrolled and allocated randomly into two groups (group D and group P). After measurement of initial IOP with topical opthalmic anesthetics, general anesthesia will be induced with pentothal sodium 5-6mg/kg (group D) or propofol (group P) 2-2.5mg/kg. After administration of muscle relaxant and intubation, intraocular pressure will be measured and anesthesia will be maintained with desflurane (group D) or propofol (group P) and all patients will be administered intravenous remifentanil concurrently during anesthesia. During anesthesia, IOP will be measured at different patient positions. At the time of each IOP measurements, the following data set will be collected: mean arterial pressure (MAP), End tidal carbon dioxide (EtCO2), peak inspiratory pressure (PIP).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing laparoscopic colorectal surgery American society of anesthesiologist physical status class I or II

排除标准

  • opthalmic disease or previously undergone opthalmic surgery, uncontrolled hypertension, arrythmia, psychiatric disorder, uncontrolled obstructive lung disease

研究组 & 干预措施

Desflurane

Active Comparator

inhalation anesthesia administration for maintenance of anesthesia

干预措施: Desflurane (Drug)

Propofol

Active Comparator

intravenous anesthesia administration for maintenance of anesthesia

干预措施: Propofol (Drug)

结局指标

主要结局

changes in intraocular pressure (IOP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.

时间窗: before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation

T1 (baseline: initial IOP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)

次要结局

  • changes in mean arterial pressure (MAP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.(before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation)
  • changes in end tidal carbon dioxide in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.(immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation)
  • changes in peak airway pressure in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.(immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation)

研究者

发起方
Saint Vincent's Hospital, Korea
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seo, Kwon Hui

Clinical Assistant Professor, Department of anesthesia and pain medicine, Saint Vincent's Hospital, Korea

Saint Vincent's Hospital, Korea

研究点 (1)

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