Remimazolam for Postoperative Sleep in Elderly Patients

NCT07740343 | Not Yet Recruiting

• 1 other identifier: RMZ on postoperative sleep
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Postoperative Sleep

Keywords

postoperative sleep

Outcome Measures

Primary Outcomes (1)

• Total sleep time (TST) on the first postoperative night

  Polysomnography (PSG) was used to assess total sleep time on the first postoperative night in both groups.

  On the first postoperative night

Secondary Outcomes (13)

• 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

Study Arms (2)

Remimazolam (Group R)

EXPERIMENTAL

Remimazolam was used for both anesthesia induction and maintenance

Drug: Remimazolam

Propofol (Group P)

ACTIVE COMPARATOR

Propofol was used for both anesthesia induction and maintenance.

Drug: propofol

Interventions

Remimazolam DRUG

In the remimazolam group, anesthesia was induced with remimazolam 0.2 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. After 3 minutes of preoxygenation, tracheal intubation was performed, and mechanical ventilation was initiated to maintain PETCO₂ at 30-40 mmHg. Anesthesia was maintained with continuous infusions of remimazolam and remifentanil, guided by anesthetic depth monitoring. Rocuronium was supplemented intermittently and discontinued 30 minutes before the end of surgery.Polysomnography (PSG) was performed both preoperatively and postoperatively to measure total sleep time and sleep architecture. Subjective sleep quality was assessed using validated questionnaires during postoperative follow-up.

Remimazolam (Group R)

propofol DRUG

In the propofol group, anesthesia was induced with propofol 1.0-1.5 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. Anesthesia was maintained with continuous infusions of propofol and remifentanil. All other procedural details were identical to those in the remimazolam group.

Propofol (Group P)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07