The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change from baseline in systolic arterial pressure after premedication
研究概览
简要总结
The aim of this study will be to investigate the effect of opioid-free induction versus opioid-based induction on hemodynamic response and nociception level index during elective operations
详细描述
Laryngoscopy and intubation stimuli can cause a sustained sympathetic response manifested as hypertension and tachycardia. Therefore, preadministration of opioid medication aiming at blunting this hemodynamic response is common in everyday anesthetic practice.
Opioid-based anesthesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.
Research in recent years has focused on the quest for non-opioid-based regimens (opioid-sparing and opioid-free techniques). Most of the relevant studies however focus on the advantages that opioid-free techniques bear on early and late postoperative patient recovery. Literature on the effect of opioid-free techniques especially on laryngoscopy, intubation and subsequent hemodynamic response.
Therefore, the aim of this study will be the comparison of the hemodynamic response to laryngoscopy and intubation between two groups of patients: a group in which opioid medications will be administered before anesthetic induction and a group in which a combination of lidocaine, dexmedetomidine and ketamine will be administered before anesthetic induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •adult patients
- •American Society of Anesthesiologists (ASA) classification I-II
- •Mallampati classification 1, 2 or 3
排除标准
- •anticipated difficult airway (Mallampati 4 classification, thyromental distance < 6 cm, mouth opening < 3 cm, neck extension< 80
- •atrioventricular block
- •bradycardia (heart rate less than 55/min)
- •preadministration of beta-blockers
- •eligibility for rapid-sequence induction
- •chronic use of opioid medications
- •known allergy to induction agents
- •history of psychiatric disease
- •language or communication barriers or lack of informed consent
研究组 & 干预措施
ketamine-lidocaine-dexmedetomidine group
combination of ketamine-lidocaine-dexmedetomidine
干预措施: ketamine-lidocaine-dexmedetomidine (Drug)
fentanyl group
fentanyl
干预措施: fentanyl (Drug)
结局指标
主要结局
change from baseline in systolic arterial pressure after premedication
时间窗: 30 seconds after premedication
baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure immediately after premedication
时间窗: immediately after intubation
baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure 3 minutes after intubation
时间窗: 3 minutes after intubation
baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure 5 minutes after intubation
时间窗: 5 minutes after intubation
baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure after premedication
时间窗: 30 seconds after premedication
baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure 1 minute after intubation
时间窗: 1 minute after intubation
baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure 1 minute after intubation
时间窗: 1 minute after intubation
baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure 3 minutes after intubation
时间窗: 3 minutes after intubation
baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure 5 minutes after intubation
时间窗: 5 minutes after intubation
baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate after premedication
时间窗: 30 seconds after premedication
baseline heart rate will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate 1 minute after intubation
时间窗: 1 minute after intubation
baseline heart rate will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate 3 minutes after intubation
时间窗: 3 minutes after intubation
baseline heart rate will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate 5 minutes after intubation
时间窗: 5 minutes after intubation
baseline heart rate will be measured as soon as the patient settles in the operating theatre
ST segment change 1 minute post intubation
时间窗: 1 minute after intubation
ST segment elevation or depression after intubation
ST segment change 3 minutes post intubation
时间窗: 3 minutes after intubation
ST segment elevation or depression after intubation
ST segment change 5 minutes post intubation
时间窗: 5 minutes after intubation
ST segment elevation or depression after intubation
duration of nociception level<25 for a 5-minute period after intubation
时间窗: 5 minutes after intubation
nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels\<25 suggest adequate intraoperatively analgesia
time required to achieve a train-of four-ratio of 0
时间窗: within 2.5 minutes of neuromuscular blocking agent administration
the train-of-four (TOF) ratio measures the ratio of the fourth stimulus to the first stimulus of four twitches of neuromuscular stimulation. When this ration reaches the value of 0, the patient is considered ready for intubation
次要结局
未报告次要终点
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital