Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Total sleep time (TST) on the first postoperative night
研究概览
简要总结
Postoperative sleep disturbance (PSD) is highly prevalent in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Although remimazolam has shown favorable sedative properties and may alleviate perioperative stress, its effects on postoperative sleep architecture remain poorly understood. Polysomnography (PSG), the gold standard for objective sleep assessment, has not been widely used to evaluate these effects in this population. Therefore, this study employs a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, thereby offering more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic colorectal cancer surgery.
详细描述
Laparoscopic radical resection of colorectal cancer is the most commonly used surgical approach for colorectal cancer in elderly patients. Although this technique is less invasive than traditional open surgery, more than 60% of elderly patients still experience significant sleep fragmentation and disturbance in the early postoperative period, making effective sleep preservation a key component of enhanced recovery after surgery (ERAS).
Sedative agents play a critical role in modulating perioperative sleep patterns. Remimazolam, a novel ultra-short-acting benzodiazepine, is considered a promising anesthetic for elderly patients due to its favorable pharmacokinetic profile and minimal dependence on hepatic and renal function. However, its impact on objective sleep architecture remains unclear. Propofol, the most widely used sedative in general anesthesia, has been reported to disrupt sleep cycles in the postoperative period, with inconsistent effects on slow-wave sleep and rapid eye movement (REM) sleep.
Polysomnography (PSG) is the gold standard for assessing sleep architecture, including total sleep time, sleep efficiency, sleep stage distribution, and arousals. Previous studies have demonstrated that remimazolam is associated with improvements in subjective sleep outcomes in surgical patients. However, current research on remimazolam's effects on postoperative sleep after laparoscopic colorectal cancer surgery remains limited, particularly lacking high-quality, prospective, randomized controlled studies using objective PSG measurements to verify whether remimazolam can achieve superior sleep outcomes compared with propofol. Therefore, this study adopts a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, providing more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic radical resection of colorectal cancer.
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, Outcomes Assessor)
盲法说明
A randomized, double-blind, controlled design was employed in this study. Patients were randomly assigned to receive either remimazolam or propofol for anesthesia induction and maintenance. Both patients and outcome assessors were fully blinded to group allocation and the type of study drug administered.
Investigators (anesthesiologists) performed anesthesia according to pre-assigned blinded codes and did not participate in any outcome assessment. Outcome assessors were independent, well-trained researchers who were not involved in anesthesia or clinical care; they solely conducted postoperative sleep monitoring, scale scoring, and data collection.
All study medications, including remimazolam and propofol, were prepared, labeled, and coded by an independent third party who did not take part in any clinical treatment or assessment procedures. This design effectively eliminated observer bias and measurement bias, ensuring the objectivity and reliability of the results.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 65 and 80 years.
- •Scheduled for elective laparoscopic radical resection of colorectal cancer.
- •American Society of Anesthesiologists (ASA) physical status class II-III.
- •Able to understand the study protocol and provide written informed consent.
排除标准
- •Known allergy to any study medications.
- •Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] score > 10).
- •Regular use of sedatives, antipsychotics or hormonal drugs within the past month.
- •Preoperative cognitive impairment, screened using the education-adjusted Mini-Mental State Examination (MMSE).
- •Preoperative history of neurological or psychiatric disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety disorders.
- •Severe preoperative comorbidities involving the cardiovascular, cerebrovascular, respiratory, hepatic or renal systems, as follows:New York Heart Association (NYHA) functional class IV; current or recent (within 2 months) congestive heart failure; myocardial infarction or coronary stent implantation within the preceding 3 months; Uncontrolled frequent ventricular premature beats (>5 beats per minute), couplets, triplets, paired ventricular arrhythmias, multifocal ventricular premature beats, or R-on-T phenomenon; Second-degree atrioventricular block (Mobitz II type), third-degree atrioventricular block or sick sinus syndrome without pacemaker implantation; Stroke or transient ischemic attack within the preceding 3 months; Severe hypertension (blood pressure ≥ 180/110 mmHg); Severe respiratory tract infection (including common cold), or maximal voluntary ventilation (MMV) < 30% of the predicted value; Severe hepatic dysfunction (Child-Pugh score > 9); Acute or chronic renal failure without renal replacement therapy: Acute kidney injury was defined as an absolute increase in serum creatinine ≥ 0.3 mg/dL (≥26.5 μmol/L) or a relative increase ≥ 50% from baseline, or urine output < 0.5 mL/(kg·h) for more than 6 consecutive hours. Chronic renal failure or uremia was defined as serum creatinine > 451 μmol/L and estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
- •Severe coagulation disorders.
- •Refusal to participate in the trial.
- •Anticipated postoperative admission to the intensive care unit (ICU).
研究组 & 干预措施
Remimazolam (Group R)
Remimazolam was used for both anesthesia induction and maintenance
干预措施: Remimazolam (Drug)
Propofol (Group P)
Propofol was used for both anesthesia induction and maintenance.
干预措施: propofol (Drug)
结局指标
主要结局
Total sleep time (TST) on the first postoperative night
时间窗: On the first postoperative night
Polysomnography (PSG) was used to assess total sleep time on the first postoperative night in both groups.
次要结局
- Richards-Campbell Sleep Questionnaire (RCSQ) Score(Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 7)
- Pittsburgh Sleep Quality Index (PSQI) Score(1 month postoperatively)
- Resting Visual Analogue Scale (VAS) Pain Score(at 1, 2, and 3 days postoperatively)
- The incidence of postoperative delirium(at 1, 2, and 3 days postoperatively)
- Postoperative cognitive function(at 7 days postoperatively and at 1 month postoperatively)
- Sleep efficiency assessed by polysomnography (PSG)(Postoperative Night 1)
- Number of awakenings after sleep onset assessed by polysomnography (PSG)(Postoperative Night 1)
- Total wake time assessed by polysomnography (PSG)(Postoperative Night 1)
- Proportion of each sleep stage assessed by polysomnography (PSG)(Postoperative Night 1)
- Serum levels of cortisol(on the morning of postoperative day 1)
- Movement Visual Analogue Scale (VAS) Pain Score(Postoperative Day 1, Postoperative Day 2, Postoperative Day 3)
- Serum C-reactive protein (CRP) level(Morning of postoperative day 1)
- Serum interleukin-6 (IL-6) level(Morning of postoperative day 1)