Changes in cerebral vasodilation induced by sevoflurane, isoflurane, desflurane and the influence of these changes on intraoperative brain conditions in patients undergoing resection of gliomas under general anaesthesia- A Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To correlate changes in Transcranial doppler parameters with 1 MAC concentration of sevoflurane, isoflurane and desflurane with:
研究概览
简要总结
Inhalational agents in today’s clinical practice alter the cerebral hemodynamics in a dose dependent fashion. Upwards of 1.0 MAC concentration cerebral vasodilatation is seen as intrinsic vasodilatory action of the volatile agents as well as decreased cerebral resistance. The magnitude of cerebral vasodilatation is not uniform amongst the three widely used inhalational agents as shown by both human and animal studies. Cerebral vasodilatation is known to alter cerebral hemodynamics. Adequate brain relaxation is essential for neurosurgery to provide sufficient surgical exposure thereby minimising the risk of damage to the normal brain tissue. Presence of supratentorial tumors may impair cerebral autoregulation more so if the midline shift is more than 5 mm. As estimated by the neurosurgeons, subdural pressure monitoring after removal of bone flap correlates well with the dural tension. There are lack of methods by which cerebral blood flow (CBF) can be measured directly. There are lack of methods by which cerebral blood flow can be measured directly. However, CBF can be indirectly measured by trans-cranial doppler (TCD) . When angle of insonation and vessel diameter remains constant, the middle cerebral artery (MCA) flow velocity provides an indirect measure of cerebral blood flow. Cerebral blood flow changes due to volatile agents can be assessed by the MCA flow velocity as change in the MCA flow velocity is directly proportional to the change in CBF and TCD is a surrogate of CBF.
Pulsatility index (PI) is a non-invasive method of assessing vascular resistance in major blood vessels with the use of Doppler ultrasonography. PI more than 1.5 in Middle Cerebral artery using Transcranial Doppler has been shown to be an indicator of increased Intracranial Pressure.
A previous unpublished study has shown that Isoflurane has a better cerebral hemodynamic profile amongst the three inhalational agents viz. Isoflurane, Desflurane and sevoflurane with respect to TCD study of MCA flow velocities at equi-MAC concentrations under steady state anesthesia.
However, does the same observation translate into clinical results with respect to intraoperative brain condition was not studied in the previous study. Hence, we propose to conduct a randomized controlled trial to test the clinical translation.
In this randomized control trial, we propose to assess the changes in MCA flow velocities amongst the three volatile agents and correlating the findings with the intraoperative brain condition by using the brain relaxation score and subdural pressure measurements in patients with unilateral glioma (supratentorial tumor).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •1.Patients with Supratentorial Lesion glioma only.
- •2.Age group 18 to 60 years.
- •3.ASA physical grade I and II.
排除标准
- •1.Patients with poor acoustic temporal window.
- •2.Hemodynamically unstable patient requiring inotropic infusion.
- •3.Plaques or Stenosis observed on Carotid Artery Doppler in the preoperative period.
- •4.Midline shift of more than 5mm.
- •5.Refusal of Consent.
结局指标
主要结局
To correlate changes in Transcranial doppler parameters with 1 MAC concentration of sevoflurane, isoflurane and desflurane with:
时间窗: the primary outcome will be measured with a baseline transcranial doppler parameters prior to induction of anaesthesia, fifteen minutes post induction of anaesthesia and subdural pressure will be monitored post craniotomy.
A) intraoperative brain relaxation score (subjective) B) Sub dural pressure measurement (objective)
时间窗: the primary outcome will be measured with a baseline transcranial doppler parameters prior to induction of anaesthesia, fifteen minutes post induction of anaesthesia and subdural pressure will be monitored post craniotomy.
次要结局
- To compare the effect of all three inhalational agents on 1.hemoglobin mass loss in the intra-operative period.(2.The compare the effect of all three inhalational agents on emergence delirium and post operative delirium)
研究者
Dr RAKSHA ANAND
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
