Impact of Chronic Treatment by β1-adrenergic Antagonists on Nociceptive-Level (NOL) Index Variation After a Standardized Noxious Stimulus Under General Anesthesia: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- NOL variation (NOL is an index without unit) before and after stimulation (delta NOL), no unit, varies from 0-100
研究概览
简要总结
The aim of the present study is to investigate the effect of chronic treatment with β1-adrenergic antagonist on the NOL index variation, the heart rate variation and the mean blood pressure variation after a standardized noxious stimulus.
详细描述
Hypothesis: We hypothesize that the NOL values variations obtained in response to a standardized noxious stimulus under general anesthesia in a group of patients chronically treated with β1-adrenergic antagonists, will be similar to the NOL values variations previously obtained in response to a similar standardized noxious stimulus and previously reported in a group of patients without any β1-adrenergic antagonist.
Background: The Pain Monitoring Device (PMD200TM) monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) uses the Nociception Level (NOL) index, a multiple parameter-derived index that has recently shown a good sensitivity and specificity to detect noxious stimuli. The NOL index variations of the latest version of the PMD200TM has shown better sensitivity and specificity to detect standardized noxious stimulus than heart rate or blood pressure variation in a population without any β1-adrenergic antagonist treatment. β1-adrenergic antagonist treatment was so far a limitation to the use of the NOL index. Indeed, β1-adrenergic antagonists have a depressive action on the heart rate, including limitation of the heart rate variability after a noxious stimulus. Because heart rate and its variability are parameters which are part of the parameters combined to build the NOL index, chronic treatment with β1-adrenergic antagonist could alter the ability of the NOL index to detect noxious stimulus. However, Edry R. (Edry R, 2017) assessed the impact of chronic treatment with β1-adrenergic antagonist on NOL index variation after noxious stimuli in a pilot study (9 patients under chronic treatment with β1-adrenergic antagonist and under general anesthesia) and didn't show any influence of this treatment on the NOL index variation. But this study was not large enough and did not fully answered the question whether chronic treatment with β1-adrenergic antagonist might impact NOL ability to detect precise and standardized stimulus and to compare the results to those in patients without this type of chronic medication.
Objectives:
Primary objective:
To explore the NOL variation in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient age > 18 years
- •Adult patients scheduled to undergo elective surgery under general anesthesia
- •Patients chronically treated with β1-adrenergic antagonists for at least three months prior to surgery
- •Patient able to consent in the language of the including center
排除标准
- •Use of any type of anesthesia (neuraxial, epidural or local regional anesthesia) without general anesthesia
- •Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, and antiarrhythmic agents others than β1-adrenergic antagonists
- •Emergent surgery
- •Pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
- •BMI > 40 kg/m2
- •Preoperative hemodynamic disturbance
- •Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
- •Peripheric nervous system disorder (troubles of the peripheric nervous conduction, diabetic neuropathy)
- •Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
- •Chronic use of psychoactive drugs within 90 days prior to surgery
- •Medical conditions qualifying for ASA III or IV:
- •Untreated or persistent peripheral or central cardiovascular disease
- •Severe pulmonary disease e.g. COPD gold 4, FEV< 1.0l/s, or (evidence of) elevated paCO2 > 6.0 kPa
- •Significant hepatic disease with increased bilirubin, INR or low albumin
- •History of severe cardiac arrhythmia eg. Chronic atrial fibrillation.
- •Active pacemaker or defibrillator
- •Allergy or intolerance to any of the study drugs
- •Cardiac arrhythmia during the period of the study
- •Unexpected difficult airway requesting excessive, possibly painful airway manipulations
结局指标
主要结局
NOL variation (NOL is an index without unit) before and after stimulation (delta NOL), no unit, varies from 0-100
时间窗: Intraoperative, during anesthesia
To explore the NOL variation between NOL average values before tetanic stimulation at the forearm level, and peak of NOL after stimulation (peak will be considered as an average values of 5 values around the maximal value of NOL, as the definition already used in previous studies) in a group of patients under chronic treatment with β1-adrenergic antagonists submitted to standardized noxious stimulus under general anesthesia.
次要结局
- NOL variation (NOL is an index without unit) before and after tracheal intubation (delta NOL), no unit, varies from 0-100(Intraoperative, during anesthesia)
- Heart Rate variation before and after tetanic stimulation (delta heart rate), in beats per minute(Intraoperative, during anesthesia)
- Heart Rate variation before and after intubation (delta heart rate), in beats per minute(Intraoperative, during anesthesia)
- Mean blood pressure variation before and after stimulation (delta mean blood pressure), in mmHg(Intraoperative, during anesthesia)
- Mean blood pressure variation before and after intubation (delta mean blood pressure), in mmHg(Intraoperative, during anesthesia)
- Bispectral index (BIS) variation before and after stimulation (delta BIS), no unit, varies from 0-100(Intraoperative, during anesthesia)
- Bispectral index (BIS) variation before and after tracheal intubation (delta BIS), no unit, varies from 0-100(Intraoperative, during anesthesia)
研究者
Philippe Richebe
Professor Anesthesiology and Pain Medicine
Ciusss de L'Est de l'Île de Montréal