Does Bispectral Index Improve Surgical Conditions During Fast Track Gynecological Benign Laparoscopies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Proportion of optimal surgical field score
研究概览
简要总结
This study investigates whether BIS monitor assisted anesthesia improves surgical space conditions during gynecological benign laparoscopic procedures.
Half of participants will receive BIS monitor assisted anesthesia, while the other half will receive anesthesia without BIS monitor.
详细描述
General Anesthesia includes hypnosis/unconsciousness, amnesia, analgesia, muscle relaxation and autonomic and sensory blockade of responses to noxious stimulation.
Depth of anesthesia in standard practice is controlled by monitoring equipment such as blood pressure (BP), heart rate (HR), train of four ratio (TOF) and by clinical signs such as profuse sweating, tearing, cough and movements.
BIS can be used as additional tool to monitor and manage anesthesia. BIS is an empirically derived scale for measuring brain electrical activity. It computes an index between 0 and 100, whereas 0 corresponds to "no detectable brain electrical activity" (flatline EEG) and 100 to awake state. A patient is considered to be appropriately anesthetized when the BIS' value is between 40 and 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged > 18 years
- •American Society of Anesthesiology (ASA) physical status 1 or 2
- •Legally competent
排除标准
- •Age < 18 years
- •ASA physical status ≥3
- •Renal and/or lever disease
- •Relevant allergies towards anesthetics
- •Cancer surgery
- •No informed consent or inability to give that
结局指标
主要结局
Proportion of optimal surgical field score
时间窗: up to 12 hours
score 1 on a scale 1-4 (higher values represent a better outcome)
次要结局
- Administration of neuromuscular block(up to 12 hours)
- Amount of analgesics administered in PACU(1 day)
- BIS values (continues)(up to 12 hours)
- Amount of anesthetics, narcotic analgesics and other adjuvants(up to 12 hours)
- Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)(1 day)
研究者
Elena Crescioli
Principal Investigator
Aalborg University Hospital