Determination of the ED50 and ED95 of Remifentanil to Perform Tracheal Intubation Without Significant NOL Index Variation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation
研究概览
简要总结
Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. In order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the Macintosh laryngoscope, the most common tool used for intubation in the operating room
详细描述
Background: There are no study so far that determined the ED50 and ED95 of remifentanil to perform tracheal intubation by using the NOL index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure.
Objectives: To determine the ED50 and ED95 of remifentanil bolus to perform tracheal intubation without NOL index variating over threshold for nociceptive response (determined as a NOL index going over 20 - peak value of maximum 20) using the Macintosh blade when obtaining good conditions of intubation in anesthetized patients. Good conditions of intubation will be determined as obtaining a Cormack-Lehane grade I and II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
remifentanil will be given by a dosage of 0.5-1.0-1.5-2.0 µg/kg of adjusted body weight bolus according to randomization, by an infusion pump over 30 seconds
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 or II
- •Mallampati class I or II
- •Patients > 18 years old and <65 years (defining elderly patients)
- •Elective general, gynecological, orthopedic, plastic or urological surgery under general anesthesia
- •Type of surgery that usually necessitate endotracheal intubation and controlled ventilation
排除标准
- •Patient refusal
- •History of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier.
- •Anticipated difficult airway (Mallampati class III and IV, thyromental distance < 6 cm, mouth opening < 3 cm, neck extension <80° and neck flexion <35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla)
- •Patient with history of neck rigidity or instability
- •BMI > 30 kg/m2
- •Anticipated difficult ventilation (patients with beard, obesity with BMI more than 30 kg/m2)
- •Patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy, tonsillectomy and teeth removal)
- •Severe coronary artery disease
- •Serious cardiac arrhythmias (including atrial fibrillation)
- •Use of β-blockers (all types)
- •History of opioid or illicit drug substance abuse
- •Chronic use of psychotropic and/or opioid drugs
- •Allergy to remifentanil or propofol
- •Pregnancy
- •Contraindications to mask ventilation (gastrointestinal tract obstruction, pregnancy, active not-treated gastroesophageal reflux disease, non-fasting patients)
- •Unexpected difficult airway requesting excessive, possibly painful airway manipulations
- •Requiring hemodynamic support with vasopressors or inotropes 2 min before laryngoscopy to 5 min after insertion of endotracheal tube
研究组 & 干预措施
Remifentanil dose 0.5 ug/kg
Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.
干预措施: Remifentanil dose 0.5 ug/kg (Drug)
Remifentnil dose 1 ug/kg
Remifentanil will be given (dosage of 1.0 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.
干预措施: Remifentanil dose 1 ug/kg (Drug)
Remifentanil dose 1.5 ug/kg
Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.
干预措施: Remifentanil dose 1.5 ug/kg (Drug)
Remifentanil dose 2 ug/kg
Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.
干预措施: Remifentanil dose 2 ug/kg (Drug)
结局指标
主要结局
determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation
时间窗: in the surgery
The primary goal of this study is to determine the ED95 of remifentanil bolus to perform tracheal intubation without NOL index varying over 20 (peak maximal value of 20) using the Macintosh blade when obtaining a Cormack-Lehane grade I or II of intubation in anesthetized patients (the size of the blade will be chosen according to patient characteristics described in the user's manual for each blade and published in previous literature). This primary outcome will be expressed in mcg/kg of remifentanil.
次要结局
- NOL maximal value after intubation (NOL is an index without unit going from 0 to 100)(in the surgery)
- Variation of NOL index after tracheal intubation; DELTA NOL (no unit)(in the surgery)
- Time in seconds NOL spends above 25 after tracheal intubation (in seconds)(in the surgery)
- Area under the curve for NOL index after tracheal intubation (no unit)(in the surgery)
- Heart Rate Maximal value after tracheal intubation (in beat per minutes)(in the surgery)
- Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute)(in the surgery)
- Time in seconds that Heart Rate spends above threshold of 10%; in seconds(in the surgery)
- Area under the curve of Heart Rate after tracheal intubation (no unit)(in the surgery)
研究者
Philippe Richebe
Director of Research in the Department of Anesthesiology
Ciusss de L'Est de l'Île de Montréal