Interest of the Gradient of Nociceptive Indexes After a Tetanus (100 Hz, 60 Milliamperes, 30 Seconds) at a Fixed Remifentanil Effect Site Concentration to Adjust Remifentanil Before Tracheal Intubation and Skin Incision
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- hemodynamic stability following tracheal intubation and surgical incision
研究概览
简要总结
Individually-tailored administration of the opioid analgesic component during general anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to look if the gradient response of a nociception index to a calibrated tetanic stimulus during standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal intubation and before skin incision. The studied parameters are the SPI index developed by General Electric, the "Analgesia Nociception Index" and the pupil dilation using the pupil scan algometer.
详细描述
Two randomized groups of patients scheduled for general surgery under Target Controlled remifentanil propofol anaesthesia are compared.
All patients receive two standard calibration tests (Tetanic stimulus at the ulnar nerve: 100 Hertz, 60 milliamperes, 30 seconds) before tracheal intubation and skin incision at a stable remifentanil level of 3 ng/ml. Propofol concentration is targeted to maintain the BIS value as close as possible to 50. Patients are mechanically ventilated at an inspired O2 concentration of 50% and using tidal volumes of 8 to 10 mL/kg and respiratory rates of 12 to 15/min. Patients receive an induction dose of neuromuscular blocking agent.
In the treated group, the importance of the Surgical Plethysmogram Index (SPI) gradient after the tetanic stimulus will guide the subsequent administration of remifentanil to cover tracheal intubation and surgical incision. As compared to SPI value before the calibration test, a less than 10 unit increase in SPI will not prompt any change in remifentanil concentration before tracheal intubation and surgical incision. An increase in SPI between 10 and 20 units will prompt a remifentanil effect-site target concentration of 4 ng/ml, between 20 and 30 of 5 ng/ml, and above 30 of 6 ng/ml for tracheal intubation. Once the trachea is intubated, remifentanil concentration will be lowered to 3 ng /ml. It will be adjusted again before surgical incision according to the same criteria. Ten minutes after surgical incision until the end of the surgical procedure, the remifentanil concentration will be targeted to maintain SPI between 20 and 50.
In the control group, conditions will be the same as those of first group, except that remifentanil concentration will be adjusted according to heart rate and blood pressure. The anesthesiologist in charge is blinded to the results of the SPI gradient after the two calibration tests at 3 ng/ml remifentanil concentration and also blinded to the 2 other nociception indexes at all times. Remifentanil concentration is targeted at 4 ng/ml before tracheal intubation and surgical incision. Ten minutes after skin incision until the end of surgery, remifentanil concentrations will be adjusted according to the hemodynamic parameters.
Data acquisition and analysis will lead to the following statistical comparisons between the two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Informed consent obtained during the pre-anesthetic visit
- •American Society Anesthesiology status I or II
- •Scheduled surgery under general anesthesia, and necessitating endotracheal intubation and controlled mechanical ventilation
- •Body mass index (BMI) between 17 and 30 kg/m2
排除标准
- •Pregnancy
- •Patient refusal
- •Pace maker (all modes)
- •Heart failure
- •Ejection fraction < 50%
- •Symptomatic aortic or mitral pathology
- •Non sinus rhythm
- •Chronic use of beta blocking agents or other anti-hypertensive medications, except for diuretics
- •Dysautonomia
- •Spontaneous ventilation during anesthesia
- •Allergy to one of the medications used during this experiment
研究组 & 干预措施
SPI group
Remifentanil titration before tracheal intubation and skin incision according to the SPI gradient obtained after a nociceptive test using a tetanic stimulus of 100 Hz, 60 milliamperes during 30 seconds performed at a 3 ng/ml level of the remifentanil concentration.
During surgery, the effect site remifentanil concentration was either increased or decreased by 1 ng/ml to maintain SPI below 40 or above 20, respectively.
干预措施: Remifentanil adapted to SPI (Drug)
Control group
The remifentanil concentration before tracheal intubation and skin incision was fixed at 4 ng/ml.
During surgery, the remifentanil concentration was adapted according to the hemodynamic answer of the patient. It was changed by 1 ng/ml stepwise variations to maintain heart rate and mean blood pressure within 20% of the patient reference hemodynamic values.
干预措施: Remifentanil fixed (Drug)
结局指标
主要结局
hemodynamic stability following tracheal intubation and surgical incision
时间窗: within 60 minutes after anesthesia induction
Improvement of hemodynamic stability at anesthesia induction if remifentanil analgesia is not fixed at a predefined value for all patients but adapted to a nociceptive test at a predefined remifentanil concentration
次要结局
- hemodynamic stability during surgery(within surgery)
研究者
Luc Barvais
Professor and head of the cardiothoracic and vascular anesthesia Clinics
Erasme University Hospital