Remimazolam vs. propofol for improving postoperative sleep in elderly colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares remimazolam to propofol as the intraoperative sedative in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Postoperative sleep quality will be assessed with objective polysomnography to measure sleep time, efficiency, stages, and arousals. The aim is to determine if remimazolam better maintains postoperative sleep architecture and reduces sleep disturbance, which is common after surgery and may impact recovery. The study uses a controlled design in a single center to generate high-quality evidence on sleep outcomes after this specific procedure. Results may inform anesthetic choices to support enhanced recovery through improved sleep in older adults.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where it's running

• General Hospital of Ningxia Medical University
  Yinchuan, Ningxia, China Recruiting

Study contacts

• Study coordinator: Liqin Deng Deng
• Email: dengliqin71@hotmail.com
• Phone: 13909511651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.