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临床试验/NCT06313320
NCT06313320招募中不适用

Determination of the Association of Intraoperative Nociception Electroencephalographic Biomarkers and Postoperative Pain

University of Chile2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Maximum Pain in PACU

研究概览

简要总结

The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain.

详细描述

This is a prospective minimal-risk observational study to collect and analyze EEG data during intraepidermal electrical stimulation in patients receiving general anesthesia (GA) for abdominal surgery. To collect nociception-related EEG signal during GA the investigators designed a standardized Intraepidermal Electrical Stimulation (IES) Protocol. The intensity of the electrical stimulus will be calibrated to each participant perception pre-surgery, with 3 different intensities: sensitivity threshold, mild-pain threshold, and moderate-pain threshold. The IES will be administered several times throughout the surgical procedure: a) At baseline, prior to induction of GA, b) Three minutes after loss of consciousness, c) Five minutes after fentanyl administration and orotracheal intubation, d) Five minutes after first incision and every 20 minutes until the end of the surgery, and f) After surgery ends and before extubation. To standardize the anesthesia management as much as possible, all patients will be attended by a reduced number of anesthesiologists. The hypnosis will be achieved with propofol, while analgesia will be mainly achieved with either fentanyl or remifentanil. EEG will be recorded with a 32-channel high standard equipment. Once the patient arrives to the Post-Anesthesia Care Unit (PACU), the investigators will record the pain reported by the patient using the Numeric Pain Rating Scale every 15 minutes during the first hour, and every 30 minutes until patient is discharged from the PACU. Also, the investigators will both, record opioid administration through the surgery and estimate their effect-site concentration with pharmacokinetic/pharmacodynamic models. Besides, the investigators will measure opioid plasmatic concentrations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist Performance Status I or II
  • Scheduled for elective laparoscopic abdominal surgery under General Anesthesia

排除标准

  • Body Mass Index > 35 kg/m2
  • Past history or suspected difficult airway
  • Craniofacial malformations
  • Use of regional anesthesia technique during or after the surgery
  • Severe arrhythmia or use of a pacemaker device
  • Severe neuropsychiatric illness (Mayor depression, bipolar disorder, schizophrenia)
  • Regular use of psychoactive drugs
  • Any injury in the right hand
  • Past history of peripheral neuropathy
  • Diabetes Mellitus
  • Known lesion in the spinothalamic tract.
  • Analgesics used in the past 72 hours
  • Known allergy to propofol
  • Previous diagnosis of a condition associated with chronic pain (such as fibromyalgia, rheumatoid arthritis, osteoarthritis, migraine)

结局指标

主要结局

Maximum Pain in PACU

时间窗: From PACU Admission to PACU Discharged, an average of 2 hours

Pain is evaluated several times during PACU stay using the Numeric Rating Scale (from 0 to 10). Discrete Numerical Variable

次要结局

  • Presence of surgical related pain at day 7(7 days after the surgery (+- 1 day))
  • Maximum Pain at 24h(From PACU discharged to 24 hours after PACU discharged)
  • Opioid Consumption in PACU(From PACU Admission to PACU Discharged, an average of 72 hours)
  • Presence of surgical related pain at day 30(30 days after surgery (+- 3 day))

研究者

发起方
University of Chile
申办方类型
Other
责任方
Sponsor

研究点 (2)

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