NCT07740343Recruiting
Remimazolam for Postoperative Sleep in Elderly Patients
Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 31 May 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- General Hospital of Ningxia Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT07740343
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Aug 2026 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular use of sedatives, antipsychotics or hormonal drugs within the past month.
Other illness
- Known allergy to any study medications.
- Preoperative sleep disorder (Pittsburgh Sleep Quality Index \[PSQI\] score \> 10).
- 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 coagulation disorders.
Lab values
- 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.
Other
- Refusal to participate in the trial.
- Anticipated postoperative admission to the intensive care unit (ICU).
Who the study is looking for
- 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.
Age in the registry: 65 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.