Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Changes in Medasense's non-invasive pain monitoring index in response to painful events.
研究概览
简要总结
In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).
The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
详细描述
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the visual analog scale (VAS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.
During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. Therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.
In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1-2
- •Elective surgery under general anesthesia
- •Baseline blood pressure < (170\100 mmHg), heart rate < 100 bpm
排除标准
- •Pregnancy or lactation
- •History of severe cardiac arrhythmias
- •Presence of any neuromuscular or neurological disease
- •Use of central nervous system (CNS) -active medications
- •Abuse of alcohol or illicit drugs
- •History of mental retardation or any mental disease
- •Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
- •Use of a α or β-adrenergic antagonist or anticholinergics
- •Allergy to any of the drugs to be used during surgery
- •Use of regional anesthesia
结局指标
主要结局
Changes in Medasense's non-invasive pain monitoring index in response to painful events.
时间窗: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.
次要结局
- Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli(before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion))
- Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli(before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion))
- Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs(before versus after analgesic drug administration)