Use of the NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane After Standardized Stimulation in Patients Under General Anesthesia. The PROSEVNOL Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Delta NOL (no unit for the NOL index)
研究概览
简要总结
The purpose of this prospective randomized controlled study is to compare the analgesic properties of propofol and sevoflurane using variation of the NOL index and standard monitoring (Heart Rate and Mean Arterial Blood Pressure) when patients under general anaesthesia with either agents are subjected to a standardized painful stimulus (a tetanic stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds).
详细描述
This study proposes a research design that compare the analgesic properties of two commonly used agents for induction and maintenance of the hypnotic component of anesthesia: propofol versus sevoflurane. Using the NOL index to quantitatively monitor nociception, it is expected to see a difference in response to a standardized electrical and tetanic stimulus during general anesthesia maintained with either agents.
Hypothesis is that magnitude of the variation and/or the value of the NOL Index following a standardized nociceptive stimulus is lower when general anesthesia is based on propofol rather than on sevoflurane.
Induction of general anesthesia will differ depending in which group the patient belongs.
In the propofol group, general anesthesia will be induced using target-controlled infusion (TCI) of propofol and remifentanil.
In the sevoflurane group, induction of general anesthesia will be carried out by spontaneous breathing through a mask while progressively opening up the dial of the sevoflurane vaporizer up to 8%. Like in the propofol group, target-controlled infusion of remifentanil is simultaneously started to reach an initial target predicted effect-site concentration of 3 ng/mL. Vaporizer is adjusted when gas equilibration reaches the patient-specific concentration 1.0 MAC of sevoflurane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •ASA status I, II or III
- •Age 18 years or older
- •Elective surgery under general anesthesia.
- •Good understanding of English or French language
- •Non-inclusion Criteria
- •Ongoing Coronary artery disease
- •Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists and antiarrhythmic agents
- •Emergent surgery
- •Pregnancy/lactation
- •Preoperative hemodynamic disturbance
- •Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
- •Patient refusal
- •Drug or alcohol abuse within the last 6 months
- •Chronic use of psychoactive drugs
- •Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
- •History of psychiatric diseases or psychological problems
- •Allergy or intolerance to any of the study drugs
排除标准
- •Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
- •Intraoperative unexpected complications requiring strong hemodynamic support (transfusions, vasopressors, inotropes)
研究组 & 干预措施
Propofol group
Induction and maintenance of general anesthesia using propofol
干预措施: Propofol (Drug)
Sevoflurane group
Induction and maintenance of general anesthesia using sevoflurane
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Delta NOL (no unit for the NOL index)
时间窗: From 1 minute before to 3 minutes after tetanic stimulation for each patient
To compare the variation of NOL (delta NOL) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
次要结局
- Delta Mean Arterial Blood Pressure (unit: mmHg)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Delta BIS (no unit for BIS index)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Peak value of NOL (no unit)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Peak value of BIS (no unit)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Area Under the Curve for NOL for Propofol Versus Sevoflurane (no unit)(From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient)
- Peak value of Heart Rate (unit: beat per minute)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Area Under the Curve for Mean Arterial Blood Pressure for Propofol Versus Sevoflurane (no unit)(From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient)
- Area Under the Curve for BIS for Propofol Versus Sevoflurane (no unit)(From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient)
- post-anesthesia care unit (PACU) Pain Scores at Rest (scale from 0 to 10)(From entrance in post-anesthesia care unit until post-anesthesia care unit discharge, an average of 2 hours)
- Delta Heart Rate (beat per minute)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Peak value of Mean Arterial Blood Pressure (unit: mmHg)(From 1 minute before to 3 minutes after tetanic stimulation for each patient)
- Area Under the Curve for Heart Rate for Propofol Versus Sevoflurane (no unit)(From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient)
- Total Dose of Sevoflurane (unit: mL)(Intraoperative)
- Total Dose of Hydromorphone in post-anesthesia care unit (PACU) (unit: mg)(From entrance in post-anesthesia care unit until post-anesthesia care unit discharge, an average of 2 hours)
- post-anesthesia care unit (PACU) Pain Scores during Cough (scale from 0 to 10)(From entrance in post-anesthesia care unit until post-anesthesia care unit discharge, an average of 2 hours)
- Total Dose of Remifentanil (unit: mcg)(Intraoperative)
- Total Dose of Propofol (unit: mg)(Intraoperative)
研究者
Philippe Richebe
Professor, MD, PhD, DESAR, Chair of Research
Ciusss de L'Est de l'Île de Montréal