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临床试验/NCT03776617
NCT03776617Unknown不适用

Regional Scalp Block With Ropivacaine 0.5% in Patients Undergoing Elective Craniotomy: a Prospective Randomized Controlled Trial

George Papanicolaou Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
heart rate fluctuation

研究概览

简要总结

This study was designed to evaluate the effect of scalp block combined with general anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients undergoing elective craniotomy. Scalp block will be applied to three groups with differences of the administered solution to the scalp and one group will be placebo group.

详细描述

Regional scalp block (RSB) is an established technique that involves infiltration of local anesthetic (LA) at well-defined anatomical sites targeting the major sensory innervation of the scalp. Regional techniques minimize anesthetic requirements and their effects may be beneficial. There is a lack of consensus and evidence concerning alternative analgesia strategies for cranial neurosurgery.

Patients undergoing elective craniotomy for tumor dissection will be randomly divided into four groups to receive scalp block as an adjuvant to general anesthesia. After a standard induction sequence using propofol, fentanyl and a single dose of rocuronium, patients will be intubated. Bilateral scalp block will be given immediately after induction, except patients in control group who will not have a scalp block. Drugs for scalp block will be 20ml ropivacaine 0.5%, 20ml xylocaine 1% and dexmedetomidine 1mcg/kg.Anaesthesia will be maintained with propofol and remifentanyl infusion. Intraoperatively, propofol infusion at 75 to 100 μg/kg/h up to dura closure and reduced to 50-75 μg/kg/h up to skin closure. Five minutes before head pinning scalp block was performed by blocking the supraorbital, supratrochlear, auriculotemporal, occipital, and postauricular branches of the greater auricular nerves.Routine monitoring of electrocardiogram, heart rate (HR), and mean arterial blood pressure (MAP) will record at two-minute intervals from the beginning of anesthesia until 10 minutes after incision, followed by 5-minute intervals throughout the remaining course of the surgery. Monitoring of the depth of anesthesia will also performed using the Bispectral Index. Sample size was calculated based on Type I error of α = 5% and power = 80% and minimum difference d = 30%, which is clinically significant in the pilot study. All quantitative variables will be reported as mean and standard deviation, and qualitative variables will be listed as number (percentage). Mann-Whitney test and Chi-square test will be used for comparison of endpoints. Linear mixed model will be used to evaluate the differences of hemodynamics variables. Statistical Package for Social Sciences (SPSS, version 19.0; SPSS Inc., Chicago, USA) will be used for all calculations. p values less than .05 will be considered significant.

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
None

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

  • patients with American Society of Anesthesiologists Physical status classification 1-3
  • patients who are scheduled for elective craniotomy for brain tumor
  • patients who have provided consent for participation in the study

排除标准

  • Patients who have allergy to local anesthetics and dexmedetomidine
  • Glasgow coma scale <15
  • tumor>4cm
  • any contraindication for receiving dexmedetomidine
  • severe mental impairment
  • pregnant women
  • uncontrolled hypertension, arrhythmia, coagulation disorder

研究组 & 干预措施

Group Ropivacaine

Experimental

general anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5%

干预措施: scalp block (Procedure)

Group Ropivacaine-Dexmedetomidine

Experimental

general anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine

干预措施: scalp block (Procedure)

Group control

No Intervention

general anesthesia

Group sham

Sham Comparator

general anesthesia + Scalp block with 40ml Normal Saline

干预措施: scalp block (Procedure)

结局指标

主要结局

heart rate fluctuation

时间窗: intraoperative

heart rate change from baseline will be calculated. The unit for heart rate is bpm

intraoperative opioid consumption

时间窗: intraoperative

The overall intravenous fentanyl and remifentanil consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.

systolic arterial pressure and diastolic arterial pressure

时间窗: intraoperative

The systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.

次要结局

  • extubation time(one day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stachtari Chrysoula MD, PhD

Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou Hospital

George Papanicolaou Hospital

研究点 (2)

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