FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- General Anaesthesia effect on Awakening
研究概览
简要总结
To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.
详细描述
The project will have a total duration of 24 months and will mainly consist of a data collection phase (months 1-24) and a data analysis and results publication phase (months 15-24). Preoperative clinical and socio-demographic data will be collected from patients' medical records. Psychological variables will be administered to the patient before elective neurosurgical surgery.
BIS-guided general anesthesia will be induced by administering sedative and analgesic drugs to the effector site Ce (Effect Site) by target-controlled infusion (TCI). Propofol and remifentanil will be titrated to maintain blood pressure, body temperature, pCO2 and SaO2 in a normal range and BIS values between 40 and 60. Pharmacological data will be relevant at the end of the intervention from the drug infusion pumps. The Recovery Room multidisciplinary team will assess the quality of awakening following the Awakening Chart (Figure 1). This assessment involves dichotomous scoring (yes/no; correct/incorrect) of specific items. To assess the recovery of consciousness, during the pre-extubation phase, simple requests/questions will be asked of the patient: show tongue; show two fingers; give phone number; state place; identify what day is today; report date of birth; notify residence; perform simple multiplication (e.g., 4x5). The following variables will be collected during the periestubation phase: cough, blood pressure ± 20% of baseline, chills, NRS > 3, RASS < -1 or > 0. An abbreviated version of the STAI questionnaire will also be administered to the patient to assess anxiety on awakening. Awakening is considered good and optimal only if a score of 13 is achieved.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled:
- •Age greater than or equal to 18 years
排除标准
- •Psychiatric illness in history and/or taking psychotropic drugs
- •Glasgow Coma Score (GCS) < 15
- •Presence of overt cognitive decline or speech disorders
- •Patients younger than 18 years of age
- •Intraoperative hypothermia (< 36°)
- •Intraoperative hypotension (MAP < 20% of baseline)
结局指标
主要结局
General Anaesthesia effect on Awakening
时间窗: 2 years
Correlation between intraoperative dosage of Propofol and Remifentanil with respect to dichotomous outcome related to quality of awakening post GA.
次要结局
- RASS Scale score(2 years)
- NRS scale score(2 years)
