Influence of Adequacy of Anaesthesia Monitoring on Both Operators' and Patients' Satisfaction in Patients Undergoing Colonoscopic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- intraoperative pain perception: 11 points numeric rating scale
研究概览
简要总结
The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively and its influence on postoperative pain perception, both patients' and operators' satisfaction in patients undergoing colonoscopic procedures under intravenous sedation using propofol and fentanyl.
详细描述
Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value > delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia.
The applicability of SPI- guided deep sedation regimen in colonoscopic procedures has not been previously studied. Additionally, depth of sedation markedly influences the nociception-antinociception balance so its monitoring also proved useful in procedures performed under deep sedation.
Therefore, we aim to investigate if both SPI-guided fentanyl administration alongside with State Entropy guided propofol aministration (Adequacy of Anaesthesia monitoring) versus State Entropy guided propofol aministration alongside with fentanyl titration based on haemodynamic parametres versus fentanyl titration based on haemodynamic parametres only influence both patients' or operator's satisfaction from anaesthetic management.
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
- Double (Participant, Care Provider)
盲法说明
Neither participant nor colonoscopic procedure provider are aware of the type of monitoring utilised during procedure.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent to participate in the study
- •written consent to undergo deep sedation for colonoscopic procedure
- •general heath condition I-III of American Society of Anaesthesiology
排除标准
- •necessity of administration of vasoactive drugs influencing SPI monitoring
- •pregnancy
- •anatomical malformation that make monitoring using SE sensor impossible
- •general atherosclerosis, heart rhythm disturbances impairing SPI monitoring
- •chronic medication using opioid drugs leading to resistancy to opioids.
研究组 & 干预措施
haemodynamic parametres-guided deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to disappearance of cilliary reflex; in the case of heart rate and/or arterial blood pressure increase by 20% a rescue dose of fentanyl 0,5 mcg per kilogram of body weight will be administered
干预措施: rescue fentanyl (Drug)
haemodynamic parametres-guided deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to disappearance of cilliary reflex; in the case of heart rate and/or arterial blood pressure increase by 20% a rescue dose of fentanyl 0,5 mcg per kilogram of body weight will be administered
干预措施: rescue propofol (Drug)
SE-guided propofol-fentanyl deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weight of fentanyl in the case of heart rate and/or arterial blood pressure increase by 20%
干预措施: rescue fentanyl (Drug)
SE-guided propofol-fentanyl deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weight of fentanyl in the case of heart rate and/or arterial blood pressure increase by 20%
干预措施: rescue propofol (Drug)
AoA-guided propofol-fentanyl deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weightof fentanyl in the case of increase of SPI value > delta 15
干预措施: rescue fentanyl (Drug)
AoA-guided propofol-fentanyl deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weightof fentanyl in the case of increase of SPI value > delta 15
干预措施: rescue propofol (Drug)
结局指标
主要结局
intraoperative pain perception: 11 points numeric rating scale
时间窗: after 2 hours after emergence from sedation
the patient will be asked if he/she had any reminiscence of pain perception during procedure of colonoscopy using 11 points numeric rating scale (0 - no pain, 10 - maximum pain)
postoperative pain perception: 11 points numeric rating scale
时间窗: immediately after emergence form sedation
the patient will be asked if he/she had any pain perception after emergence from sedation after procedure of colonoscopy using 11 points numeric rating scale (0 - no pain, 10 - maximum pain)
次要结局
- patient's satisfaction: 4 points numeric rating scale(2 hours after emergence from sedation)
- operator's satisfaction: 4 points numeric scale(immediately after the end of the procedure)