Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium Neuromuscular Blockade In Cases Of Supratentorial Tumors: A Comparative Study Between Sugammadex Versus Neostigmine
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Time to recovery of the train-of-four (TOF) ratio to 0.9
研究概览
简要总结
Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. In addition, neostigmine cannot be used to reverse profound blockade.
Anesthetics may exert their effects on various facets of cerebral function such as cerebral metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling, intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical activity. The net result of all these effects of the anaesthetic agents combined with their systemic effects may prove beneficial or detrimental to an already diseased brain.
In neurosurgical patients, clear and rapid recovery is required to early assess the neurological status and to maintain the cerebral oxygenation and metabolism within the normal physiological values which may be saved by sugammadex.
详细描述
The aim of this study is to compare Sugammadex versus neostigmine as a reversal to the neuromuscular blockade of rocuronium in patients undergoing supratentorial tumors resection. Comparison will include hemodynamics, respiratory effort and degree of sedation.
Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical class status I - III .
- •Patients scheduled for elective supratentorial brain tumor resection
排除标准
- •Severe uncompensated cardiac disease.
- •Severe uncompensated respiratory disease.
- •Severe uncompensated hepatic disease.
- •Severe uncompensated renal disease.
- •Morbidly obese patients.
- •Documented hypersensitivity to one of the used drugs.
- •Surgery in sitting position
- •Surgery in prone position
- •Patients with altered level of consciousness.
- •Pregnancy.
研究组 & 干预措施
Sugammadex
Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs
干预措施: Sugammadex (Drug)
Neostigmine
Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs
干预措施: Neostigmine (Drug)
结局指标
主要结局
Time to recovery of the train-of-four (TOF) ratio to 0.9
时间窗: For 1 hour after surgery
The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
次要结局
- Sedation level(For 1 hour after extubation)
- End-tidal carbon dioxide tension(For 6 hours after the start of surgery)
- Arterio-Jugular oxygen content difference(For 6 hours after the start of surgery)
- Estimated cerebral metabolic rate for oxygen (eCMRO2)(For 6 hours after the start of surgery)
- Cerebral Extraction Rate of Oxygen (CEO2)(For 6 hours after the start of surgery)
- Cerebral Blood Flow equivalent (CBFe)(For 6 hours after the start of surgery)
- Heart rate(For 6 hours after the start of surgery)
- Blood pressure(For 6 hours after the start of surgery)
- Central venous pressure(For 6 hours after the start of surgery)
- Peripheral oxygen saturation(For 6 hours after the start of surgery)
- Total dose of neuromuscular blockade used(For 6 hours after the start of surgery)
- Total dose of suggamadex or neostigmine used(For 30 min after the end of surgery)
- Cumulative opioids consumption(For 6 hours after the start of surgery)
- Recovery time (RT)(For 1 hour after surgery)
- Time between administration of sugammadex or neostigmine to recovery(For 1 hour after surgery)