Effect of Combined Intravenous-Inhalational Anesthesia (CIVIA) on Postoperative Recovery Patterns.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Extubation time
研究概览
简要总结
This study was planned as a single-center, prospective, randomized trial. Adult patients undergoing elective spinal surgery lasting longer than three hours, performed in a neurosurgery operating room, will be evaluated. Patients managed with three different anesthesia methods currently used will be examined for recovery patterns:
- Total intravenous anesthesia (TIVA),
- TIVA Combined anesthesia with sevoflurane and intravenous agents (sevoflurane-CIVIA),
- TIVA Combined anesthesia with desflurane and intravenous agents (desflurane-CIVIA).
Recovery patterns include; extubation time, eye opening time, emergence agitation, postoperative nausia and vomiting and postoperative recovery unit discharge time.
详细描述
The aim of this study was to compare the effects of different anesthesia methods applied in spinal surgeries lasting longer than three hours on postoperative recovery time. Specifically, it aimed to determine the contribution of low-dose (0.5 MAC) desflurane or sevoflurane combined intravenous anesthesia (CIVIA) approaches compared to total intravenous anesthesia (TIVA) on recovery parameters such as patient recovery time, extubation time, and time to consciousness. It also aimed to investigate whether the desflurane-containing combination resulted in a faster recovery than the sevoflurane-containing combination.
TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic efect site model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring.
Outputs:
Eye opening time (the time from the end of anesthesia until the patient's eye opening for verbal stimuli) Extubation time (the time from the end of anesthesia until extubation) Richardson agitation sedation and RAMSEY scale values, and Emergence agitation incidence.
Postoperative nausea and vomiting incidence (PONV). Time to discharge from the PACU and time to an Aldrate score >9 will be calculated.
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
- Double (Participant, Care Provider)
盲法说明
Participant: The participant will be unaware of which anesthesia method is involved in the perioperative period.
Care Provider: The second anesthesiologist is responsible for the patient's recovery after the anesthesia is terminated and will be unaware of which anesthetic method was used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled for spine surgery
- •Expected surgery duration longer than 3 hours
- •Use of intraoperative neuromonitoring
- •BIS-guided anesthesia administered
- •TIVA (with TCI) as the primary anesthetic technique
- •Age >18 years
排除标准
- •Emergency surgeries
- •Patients receiving sole inhaled anesthesia (no TIVA)
- •Perioperative dural injury
- •Intraoperative severe hypotension requiring inotropic support
- •Hypothermia (based on temperature measured before recovery)
研究组 & 干预措施
TIVA
Total Intravenous Anesthesia. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. Efect Site concentration will be aimed. for sole TIVA, 2-4mcg/ml propofol and 1-4ng/ml remifentanil will bu used according to BIS monitoring. 40-60 range will be used for BIS.
干预措施: Total Intravenous Anesthesia(TIVA) (Drug)
Sevoflurane combined with TIVA
Combined anesthesia with sevoflurane and intravenous agents. A 0.5 MAC sevoflurane combined with TIVA. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring.
干预措施: Sevofluorane (Drug)
Desflurane combined with TIVA
Combined anesthesia with desflurane + intravenous agents. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. Efect site concentration will be aimed for TIVA
干预措施: Desflurane (Drug)
结局指标
主要结局
Extubation time
时间窗: First postoperative hour
Extubation time in patients after all anesthetic drugs have been discontinued
Extubation time
时间窗: First postoperative hour
Extubation time in patients after all anesthetic drugs have been discontinued
次要结局
- Eye opening(First postoperative hour)
- Eye opening(First postoperative hour)
研究者
Ahmet Yuksek
Clinical Professor
Kocaeli City Hospital