Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Patients Undergoing Functional Endoscopic Sinus Surgery: a Prospective Randomized Single Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- cerebral desaturation
研究概览
简要总结
For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide effective controlled hypotension to reduce blood loss and provide a relatively blood-free surgical environment to facilitate surgery.
The goal of controlled hypotension is to maintain an arterial blood pressure which is sufficiently low to allow a reduction in bleeding with offering a superior intraoperative hemodynamic stability during stressful surgical events to maintain intact cerebral microcirculatory auto-regulation.
Auto-regulation impairment during controlled hypotension might increase oxygen extraction ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a routine basis.
Various recent studies reported based on facilitating the induction of controlled hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its effects on postoperative cognitive function are still poorly characterized. Moreover, the relationship between rSO2 and controlled hypotension has not been established in patients undergoing FESS.
Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is clinically most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion by detecting changes in rSO2 by online monitoring of cerebral oxygenation.
In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are the most commonly used hypotensive agents. The aim of this prospective randomized single blind study was to investigate the influence of remifentanyl as a hypotensive agent in comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients undergoing FESS.
详细描述
For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide effective controlled hypotension to reduce blood loss and provide a relatively blood-free surgical environment to facilitate surgery.
The goal of controlled hypotension is to maintain an arterial blood pressure which is sufficiently low to allow a reduction in bleeding with offering a superior intraoperative hemodynamic stability during stressful surgical events to maintain intact cerebral microcirculatory auto-regulation.
Auto-regulation impairment during controlled hypotension might increase oxygen extraction ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a routine basis.
Various recent studies reported based on facilitating the induction of controlled hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its effects on postoperative cognitive function are still poorly characterized. Moreover, the relationship between rSO2 and controlled hypotension has not been established in patients undergoing FESS.
Within the last decade, near infrared spectroscopy (NIRS) monitors which is clinically most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion by detecting changes in rSO2 by online monitoring of cerebral oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- 是
入选标准
- •American Society of Anesthesiology (ASA) I and II patients
- •aging between 18 and 65,
- •undergoing for elective FESS
- •requiring general anesthesia with endotracheal intubation
排除标准
- •hypertension,
- •coronary artery diseases and cerebral insufficiency,
- •severe hypovolemia and anemia,
- •body mass index over 30 kg/m2,
- •anticoagulation therapy
- •previous hypersensitivity to any of the study drugs
研究组 & 干预措施
b group
b group controlled hypotension with esmolol hydrochloride
干预措施: Esmolol Hydrochloride (Drug)
r group
r group controlled hypotension with remifentanil hydrochloride
干预措施: Remifentanil Hydrochloride (Drug)
结局指标
主要结局
cerebral desaturation
时间窗: reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds through surgery completion
reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds were recorded when MAP reached the desired range (50-60 mmHg)
次要结局
- SPO2 value(SPO2 value at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion)
- Heart rate(Heart rate at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion)
- cognitive function of the patients(cognitive function of the patients were assessed 1 hour before surgery and 120 minutes after the discontinuation of the drugs)
- the duration of surgery(duration of the surgery from the beginning of the surgery up to the end of the surgery)
- duration of anesthesia(Intraoperative)
- the quality of the surgical field(When MAP reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes)
- Arterial blood pressure(arterial blood pressure at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion)
- the consumption dose of hypotensive agents(Intraoperative)
- desaturated and not desaturated patients among the groups(Intraoperative)
- cerebral oxygen saturation(Intraoperative)
研究者
Demet Altun
attending anesthesiologist
Istanbul University