Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Sleep | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| propofol | Drug | — | UNRESOLVED |
| Remimazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remimazolam (Group R)
- description
- Remimazolam was used for both anesthesia induction and maintenance
- interventionNames
- Drug: Remimazolam
- type
- ACTIVE_COMPARATOR
- label
- Propofol (Group P)
- description
- Propofol was used for both anesthesia induction and maintenance.
- interventionNames
- Drug: propofol
Primary outcomes (1)
- measure
- Total sleep time (TST) on the first postoperative night
- timeFrame
- On the first postoperative night
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (0)
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