Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- 15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1
研究概览
简要总结
This study aims to assess whether electroencephalogram (EEG) and nociception level-guided anesthesia can improve quality of recovery after laparoscopic gynecological surgery compared with standard care. Patients will be randomly assigned to either EEG and Analgesia Nociception Index (ANI)-guided anesthesia group (EEG-and-ANI-Guided group) or usual care group (control group). Primary outcome is 15-item Quality of Recovery (QoR-15) score at postoperative day (POD) 1. Secondary outcomes included remifentanil consumption during anesthesia, occurrence of awareness with recall, incidence of undesirable intraoperative movement, emergence time, postoperative pain scores, quality of recovery score at POD 2, and length of hospital stay.
详细描述
Adult women scheduled to undergo laparoscopic gynecologic surgery will be screened for eligibility. Patients will be randomly allocate to either the EEG-and-ANI-guided group or usual care group.
In the guided group, sevoflurane concentration will be titrated according to EEG monitoring. Intraoperative infusion of remifentanil will be titrated by ANI monitoring.
In the usual care group, EEG and ANI sensor will be attached to patients, but EEG and ANI monitor will be blinded to the attending anesthesiologists. The anesthesiologists will provide a standard care of our institution for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the anesthetic depth and analgesic dose.
Blinded investigator will assess quality of recovery questionnaire-15 at postoperative day 1 and 2.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients, medical staff who measure outcome variables, surgeons and nurses in the recovery room and wards are blinded so that medical staff and patients do not know the patient's assigned group.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients who are scheduled to undergo laparoscopic gynecological surgery.
- •Total laparoscopic hysterectomy with/without salpingo-oophorectomy
- •Laparoscopic myomectomy
- •Laparoscope-guided salpingo-oophorectomy
- •Laparoscope-guided ovarian cystectomy
- •Laparoscope-guided enucleation of ovarian cyst
排除标准
- •Patients with nonregular sinus cardiac rhythm
- •Patients with implanted pacemakers
- •Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents
- •pregnant or breastfeeding women
- •Patients who are unable to communicate
研究组 & 干预措施
EEG-and-ANI-guided group
During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring. Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression. Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.
干预措施: Sevoflurane and remifentanil (Drug)
EEG-and-ANI-guided group
During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring. Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression. Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.
干预措施: EEG-and-ANI-guided anesthesia (Procedure)
EEG-and-ANI-guided group
During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring. Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression. Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.
干预措施: EEG and ANI (Device)
Usual care group
During anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.
干预措施: standard anesthesia (Procedure)
Usual care group
During anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.
干预措施: Sevoflurane and remifentanil (Drug)
结局指标
主要结局
15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1
时间窗: 24 hours after the end of surgery
The Korean version of 15-item Quality of Recovery (QoR-15) score. Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.
次要结局
- burst suppression duration(During the operation)
- Occurrence of awareness with recall(During the operation.)
- Incidence of undesirable intraoperative movement(During the operation.)
- burst suppression ratio(During the operation)
- shivering, airway obstruction, respiratory depression, sedation in PACU(from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours)
- Remifentanil consumption during anesthesia(During surgery, from the anesthetic induction to emergence of anesthesia)
- Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)(During the operation)
- Intraoperative time ANI <50 [%](During the operation.)
- Intraoperative mean PSi(During the operation.)
- Intraoperative mean ANI(During the operation.)
- Emergence time(From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours)
- Intraoperative hypotension(During the operation)
- Intraoperative phenylephrine consumption(During the operation.)
- The incidence of post-operative nausea and vomiting(during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2)
- Patient satisfaction with anesthetic management(At post-operative 24 hours)
- Hospital length of stay(From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks)
- Intraoperative EEG burst suppression(During the operation)
- Pain numeric rating scale (NRS)(scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours)
- Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2(At post-operative 48 hours)
研究者
Dong Woo Han
Professor
Gangnam Severance Hospital