Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- pain perception intraoperatively
研究概览
简要总结
The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.
Patients received general anaesthesia alone or combined with either preemptive analgesia using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2% lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of acetaminophen in a doseof 10-15mg/kg of body weight.
详细描述
Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.
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 90 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 general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery
- •Exclusion Criteria
- •history of allergy to local anaesthetics or metamizole
- •necessity of administration of vasoactive drugs influencing SPI monitoring
- •pregnancy
排除标准
- 未提供
研究组 & 干预措施
metamizol
analgesic drug
干预措施: Metamizol (Drug)
metamizol
analgesic drug
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
acetaminophen
analgesic drug
干预措施: Metamizol (Drug)
acetaminophen
analgesic drug
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
acetaminophen
analgesic drug
干预措施: Proxymetacaine (Drug)
0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
干预措施: Acetaminophen (Drug)
0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
干预措施: Proxymetacaine (Drug)
Proxymetacaine
topical analgesia
干预措施: Acetaminophen (Drug)
Proxymetacaine
topical analgesia
干预措施: Proxymetacaine (Drug)
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
干预措施: Metamizol (Drug)
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
干预措施: Acetaminophen (Drug)
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
干预措施: Proxymetacaine (Drug)
结局指标
主要结局
pain perception intraoperatively
时间窗: intraoperatively
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively. The investigators will administer a rescue dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI value increases over 15 points in SPI scale every 5 minutes until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups
oculocardiac reflex rate
时间窗: intraoperatively
The investigators will compare the rate of presence of OCR intraoperatively in studied groups
次要结局
- pain perception postoperatively(up to one hour after discharge to postoperative unit.)
- PONV(up to one hour)
研究者
Michał Stasiowski
Principal Investigator, Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia