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临床试验/NCT04997707
NCT04997707已完成4 期

The Effect of Propofol-based Anaesthesia Versus Low Dose Propofol With Less Than Half MAC Sevoflurane on Intraoperative Trans-cranial Motor Evoked Potential During Spine Surgeries: Ratios Rather Than Values.

El-Sahel Teaching Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
TcMEP Monitoring(R2)

研究概览

简要总结

transcranial motor evoked potentials (TcMEP) were proved to be useful during complicated spinal surgeries to prevent iatrogenic complications. The effect of anesthetic agents was comprehensively discussed in literature. The Investigators studied a new balanced anesthetic protocol using propofol and sevoflurane in addition to continuous fentanyl infusion in which they compared values and ratios of amplitudes and latencies of TcMEP waves at different time point.

详细描述

This is a prospective double- blind randomized controlled study. After approval by the ethics committee at the National Cancer Institute (Cairo University) and El-Sahel Teaching Hospital (GOHTI, Cairo) and after written informed consents,46 ASA I-II patients who are scheduled for various spinal surgeries (such as: intra-spinal tumor resection, spondylolisthesis correction, traumatic spinal fractures' fixation,...) will be included in this study. Surgeons and neurophysiologists will be the same and will be blind to the anesthetic techniques in all patients.

Randomization list will be generated then patients will be randomized into two groups: control and study group.

Preoperatively, all patients will be checked for any exclusion criteria and the routine preoperative evaluation will be done. On arriving operative theater, all patients will receive 0.1 mg/kg midazolam IV. After connecting all the basic monitors' cables (NIBP, pulse oximetry and ECG) and canulating the radial artery to monitor IBP, induction of anesthesia will be done to all patients with 4μg/kg fentanyl, 2-3mg/kg propofol IV and 0.5mg/kg atracurium to facilitate endotracheal intubation. After intubation, central venous catheter( CVP), temperature probe through nasopharynx and urinary catheter will be inserted. Fentanyl infusion will be maintained in a rate of 2μg/kg/hour and will be discontinued 60 minutes before recovery.

From this time on, patients will be randomly allocated into control and study groups, each group is 30 patients; control group is the propofol (P) group and the study group is the balanced anesthesia (BA) group.

Control Group: propofol will be infused continuously in a rate of 75-100 μg/kg/min Study Group: propofol infusion in a rate of 25μg/kg/min will be given with sevoflurane. Sevoflurane concentration will be individually calculated by age-adjusted end - tidal MAC as follows: for age of 18-25 years, 26-40 years and ≥40 years MAC will be 2.6%, 2.2% and 1.8% respectively then final concentration to be delivered will be 0.2% lower than calculated half MAC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • (ASA) grades I-II who were scheduled for spinal surgeries (intraspinal tumors resection, spondylolisthesis correction, traumatic spinal fractures fixation....etc)

排除标准

  • Patients aged less than 18 years, or with history of drug abuse, any pulmonary disease, preoperative motor deficit, history of epilepsy, pacemakers and cochlear implants, previous intracranial surgeries or needed to deepen anesthetic plane during surgery

研究组 & 干预措施

P group

Active Comparator

75-100 µg/kg/min propofol

干预措施: Propofol Abbott (Drug)

P group

Active Comparator

75-100 µg/kg/min propofol

干预措施: transcranial motor evoked potential(Tcm (Diagnostic Test)

BA group

Active Comparator

25ug/kg/min propofol and 0.2% below corrected-to-age- half MAC of sevoflurane

干预措施: Propofol Abbott (Drug)

BA group

Active Comparator

25ug/kg/min propofol and 0.2% below corrected-to-age- half MAC of sevoflurane

干预措施: Sevoflurane Inhalation Solution (Drug)

BA group

Active Comparator

25ug/kg/min propofol and 0.2% below corrected-to-age- half MAC of sevoflurane

干预措施: transcranial motor evoked potential(Tcm (Diagnostic Test)

结局指标

主要结局

TcMEP Monitoring(R2)

时间窗: "up to 60 minutes"

R2), after positioning of the patient

TcMEP Monitoring(R3)

时间窗: " up to 75 minutes"

(R3) was taken after the surgical incision

TcMEP Monitoring (R1)

时间窗: " up to 45 minutes"

The first TcMEP (R1) was taken before positioning and surgical incision, at least 20-25 min

次要结局

  • Spo2(" up to 5 hours")
  • PaCo2(" up to 5 hours")
  • PHa(" up to 5 hours")
  • temperature(" up to 5 hours")
  • propofol infusion rate(" up to 5 hours")
  • end-tidal CO2(" up to 5 hours")
  • Central venous pressure (CVP)(" up to 5 hours")
  • PaO2(" up to 5 hours")
  • Train-of-four stimulation ( TOF)(" up to 5 hours")
  • R3/R2 ratio(" up to 5 hours")
  • Mean arterial blood pressure (MAP)(" up to 5 hours")
  • pulse rate(" up to 5 hours")
  • end-tidal sevoflurane(" up to 5 hours")

研究者

发起方
El-Sahel Teaching Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Samir Ahmed Ahmed ElKafrawy

consultant of anesthesia, head of neuroanesthesia unit

El-Sahel Teaching Hospital

研究点 (2)

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