Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation.
研究概览
简要总结
This study aims to assess the usefulness of pupillometry as a nociceptive indicator during elective orotracheal intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation.
详细描述
Laryngoscopy and tracheal intubation are associated with a sympathetic discharge caused by stimulation of the upper respiratory tract. Venous lidocaine is the agent most used to attenuate the hemodynamic response to laryngoscopy and intubation. Hemodynamic response might be masked by the drugs the patient is taking and its status (ex. sepsis). There's a need for an objective pain assessment method while the patient is unconscious, to maintain a proper level of analgesia and to control the hemodynamic response in order to decrease systemic repercussions.
This single-blind, randomized, single center, prospective study was approved by the Bioethics Committee of the University of Warmia and Mazury under the report number 11/2019 21st of February 2019.
Patients scheduled for elective surgery under general anesthesia with tracheal intubation were divided into three groups:
Group 1: anaesthetic induction with standard doses iv was performed (fentanyl 3mcg/kg, propofol 2mg/kg, rocuronium 0,6mg/kg).
Group 2: same as in group 1 + lidocaine 1,5mg/kg w 100ml 0,9% NaCl 10 min before intubation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physical State 1 or 2 of the American Society of Anesthesiology (ASA)
- •Electively scheduled for surgery requiring general anesthesia
- •Age >18 years
排除标准
- •Difficult airway
- •Unanticipated difficult airway based on the previous history of difficult intubation
- •Urgently scheduled for surgery requiring general anesthesia
- •Ophthalmologic pathology precluding pupillometry, ex. Horner's syndrome, Sjogrens syndrome
- •Anisocoria
- •History of opioid abuse
- •Subjects who are or may be pregnant
- •Unable to converse in Polish
- •History of psychiatric/cognitive disease
- •Patients who do not give informed consent
- •Patients with contraindications or history of hypersensitivity to lidocaine
- •Patients with coronary ischemic disease
- •Patients with atrioventricular block at any grade
- •Patients with diagnosed cardiac arrhythmias
- •Patients with heart failure
- •Patients who are taking drugs influencing the pupil size
- •Patients with pacemaker
- •Patients younger than 18 years of age
- •History of chronic pain, chronic opioid use (> 3 months)
研究组 & 干预措施
Control C
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
干预措施: Pupil reflex dilation measurement (PRD) (Device)
Control C
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
干预措施: PPI (Pupillary Pain Index) (Device)
Control C
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
干预措施: Bispectral Index (BIS) (Device)
Control C
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
干预措施: HR (Device)
Control C
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
干预措施: BP (Device)
Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
干预措施: Pupil reflex dilation measurement (PRD) (Device)
Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
干预措施: Placebo (Drug)
Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
干预措施: PPI (Pupillary Pain Index) (Device)
Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
干预措施: lidocaine (Drug)
Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
干预措施: Bispectral Index (BIS) (Device)
Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
干预措施: HR (Device)
Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
干预措施: BP (Device)
Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
干预措施: Pupil reflex dilation measurement (PRD) (Device)
Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
干预措施: PPI (Pupillary Pain Index) (Device)
Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
干预措施: Bispectral Index (BIS) (Device)
Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
干预措施: HR (Device)
Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
干预措施: BP (Device)
结局指标
主要结局
Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation.
时间窗: PRD: during the exact time of intubation (continuous measurement for 60 seconds)
Level of analgesia will be investigated in all groups (placebo, lidocaine, control) basing on the autonomous system activation during intubation by measuring variation of pupil diameter (% and mm).
次要结局
- The influence of intravenous lidocaine on level of analgesia during orotracheal intubation(PRD: during the exact time of intubation (continuous measurement for 60 seconds))
- The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.(BP - baseline and 0,1,2,3,4 minutes post-intubation)
- The influence of intravenous lidocaine on PPI(5 minutes post-intubation)
- Correlation between PRD and PPI (Pupillary Pain Index) measured using video pupillometer and BIS (Bispectral Index)(BIS - baseline, during intubation, 0,1,2,3,4,5 minutes post-intubation, PRD: during the exact time of intubation (continuous measurement for 60 seconds), PPI - 5 minutes post-intubation)
研究者
Malgorzata Braczkowska
Principal Investigator
University of Warmia and Mazury