Effect of Intraoperative Intravenous Lidocaine on the Quality of Recovery Following Colorectal Endoscopic Submucosal Dissection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Incidence of postoperative cognitive recovery
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is a common procedure that requires a long procedural time. Procedure Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures. We conducted a prospective study to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.
详细描述
Colorectal cancer occurred in more than 1.9 million new cases and 935,000 deaths in 2020 and ranked third in incidence and second in mortality globally. Endoscopic submucosal dissection (ESD) is the current standard for treating large colorectal polyps and has been shown to reduce colorectal cancer-related mortality. Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures.
Lidocaine is an amide local anesthetic with analgesic, anti-hyperalgesic, and anti-inflammatory properties. Its safety in appropriate amounts has been established. The current evidence gap is whether the use of systematic lidocaine affects the quality of recovery after ESD. Thus, the aim of this study is to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I-III;
- •Scheduled for endoscopic colorectal mucosal dissection.
排除标准
- •Patient refuses to participate;
- •BMI greater than 30;
- •Allergic or contraindication to study drugs;
- •History of chronic pain and long-term use of analgesic medication;
- •Severe arrhythmia;
- •Hepatic and renal dysfunction;
- •Any other conditions precluded study inclusion, such as cognitive impairment, pregnancy, or inability to communicate in Mandarin Chinese.
研究组 & 干预措施
Lidocaine group
Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the surgery.
干预措施: lidocaine (Drug)
Lidocaine group
Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the surgery.
干预措施: Propofol (Drug)
Placebo group
Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion.
干预措施: 0.9% saline (Drug)
Lidocaine group
Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the surgery.
干预措施: Sufentanil (Drug)
Placebo group
Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion.
干预措施: Propofol (Drug)
Placebo group
Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Incidence of postoperative cognitive recovery
时间窗: Day 3 postoperatively
Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.
次要结局
- Incidence of overall recovery(Day 7 postoperatively)
- Propofol consumption(During the colonoscopy procedure)
- Incidence of postoperative cognitive recovery(Day 7 postoperatively)
- Patient satisfaction(On 1 day postoperatively)
- Incidence of adverse events(Up to 24 hours postoperatively)
- Endoscopitst satisfacrion(At completion of colonoscopy procedure)
研究者
Yao Yusheng
Clinical Professor
Fujian Provincial Hospital