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临床试验/CTRI/2023/06/053987
CTRI/2023/06/053987尚未招募不适用

Comparison of cerebral vasodilatory effects of sevoflurane, isoflurane & desflurane in patients undergoing surgery for supratentorial lesions under general anesthesia

National Institute of Mental Health and Neurosciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To compare Change in Mean Blood Flow Velocity in Middle Cerebral Artery among the 3 Volatile anesthetics

研究概览

简要总结

Volatile anesthetics have a dual effect on cerebral vasculature. In low concentrations, they constrict cerebral vessels secondary to suppression of metabolism. With increasing concentration, the direct vasodilatory effect of volatile anesthetics turns dominant, leading to increased cerebral blood flow and brain volume. An increase in Cerebral blood volume will result in an increase in brain bulk in absence of autoregulation and eventually makes surgical access difficult.

Transcranial Doppler (TCD) provides an indirect measure of CBF by measuring blood flow velocity in Middle Cerebral artery, if the angle of insonation and vessel diameter remain constant. Although Middle Cerebral artery (MCA) flow velocity does not reflect absolute Cerebral Blood flow (CBF), change in MCA flow velocity is directly proportional to change in CBF.

Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance in major blood vessels with the use of Doppler ultrasonography. PI >1.5 in Middle Cerebral artery using Transcranial Doppler has been shown to be an indicator of increased Intracranial Pressure.

NIRS is a non-invasive monitor, well suited for repeated measurement of cerebral oxygen saturation changes. It has been used to monitor cerebral autoregulation, based on the assumption that the brain’s oxygen content is positively related to cerebral blood flow.

Isoflurane is a widely used volatile anesthetic in neurosurgical procedures and has been shown to cause cerebral vasodilatation, especially at concentrations required to induce deep plane of anesthesia.

Sevoflurane, a newer volatile anesthetic agent, is very similar to isoflurane in its cardiovascular effects. Although sevoflurane has been shown to have similar cerebral vascular effects to isoflurane in animals, this has not been a consistent finding in humans.

Desflurane, a more recently introduced volatile anesthetic agent, has been shown to induce more cerebral vasodilatation than sevoflurane and isoflurane in animals. In humans, cerebral vascular properties of desflurane are similar to that of isoflurane.

Cerebral autoregulation has been observed to be impaired in patients with large supratentorial lesion and midline shift more than 5 mm.

There has been paucity of literature on comparison of cerebral vasodilatory properties of isoflurane, sevoflurane and desflurane. There is also sparse literature on the cerebrovascular effects of volatile anesthetic agents in supratentorial lesions. To fill this knowledge gap, we propose a comparative study of cerebral vasodilatory effects of isoflurane, sevoflurane, and desflurane.

We hypothesize that Cerebral Vasodilatory Effects of Sevoflurane, Isoflurane and Desflurane are comparable in patients undergoing surgery for supratentorial lesions under surgical depth of anesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Unilateral Supratentorial Lesion ASA Physical Grade 1 and 2.

排除标准

  • Refusal of Consent Patients with Poor Acoustic Window Hemodynamically unstable patient requiring inotropic infusion Plaques/Stenosis observed on Carotid Artery Doppler in the preoperative period the day before surgery.

结局指标

主要结局

To compare Change in Mean Blood Flow Velocity in Middle Cerebral Artery among the 3 Volatile anesthetics

时间窗: Baseline to 1 MAC

次要结局

  • To compare Pulsatility Index among the 3 Volatile Anesthetics(1 MAC)
  • To compare Regional Oxygen Saturation (rS02) among the 3 Volatile Anesthetics(1 MAC)
  • To compare the effects of 1 MAC of Isoflurane Sevoflurane & Desflurane on Middle Cerebral Artery Flow Velocities between the cerebral hemisphere with tumor and normal side(1 MAC)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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