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Remimazolam for Postoperative Sleep in Elderly Patients

2 de setembro de 2026 atualizado por: General Hospital of Ningxia Medical University

Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

84

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recrutamento
        • General Hospital of Ningxia Medical University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Remimazolam (Group R)
Remimazolam was used for both anesthesia induction and maintenance
Medicamento: Remimazolam
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.
Comparador Ativo: Propofol (Group P)
Propofol was used for both anesthesia induction and maintenance.
Medicamento: propofol
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Total sleep time (TST) on the first postoperative night
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Richards-Campbell Sleep Questionnaire (RCSQ) Score
Prazo: Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 7
Subjective sleep quality assessed via the Richards-Campbell Sleep Questionnaire (RCSQ), ranging from 0 to 100 points, with a higher score indicating better sleep quality. Result interpretation: A total score < 50 indicates poor sleep quality; 50 - 69 points indicate average sleep quality; ≥ 70 points indicate good sleep quality.
Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 7
Pittsburgh Sleep Quality Index (PSQI) Score
Prazo: 1 month postoperatively
Subjective sleep quality assessed via the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21; higher scores indicate worse sleep quality.
1 month postoperatively
Resting Visual Analogue Scale (VAS) Pain Score
Prazo: at 1, 2, and 3 days postoperatively
Pain at rest was measured in both groups preoperatively and at 1, 2, and 3 days postoperatively using the Visual Analogue Scale (VAS). Scores range from 0 to 10; higher scores indicate greater pain intensity.
at 1, 2, and 3 days postoperatively
The incidence of postoperative delirium
Prazo: at 1, 2, and 3 days postoperatively
The incidence of postoperative delirium was evaluated in both groups at 1, 2, and 3 days postoperatively using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM).
at 1, 2, and 3 days postoperatively
Postoperative cognitive function
Prazo: at 7 days postoperatively and at 1 month postoperatively
Cognitive function was assessed preoperatively, at 7 days postoperatively, and at 1 month postoperatively using the Mini-Mental State Examination (MMSE). Scores range from 0 to 30; higher scores indicate better cognitive function.
at 7 days postoperatively and at 1 month postoperatively
Sleep efficiency assessed by polysomnography (PSG)
Prazo: Postoperative Night 1
Sleep efficiency measured by polysomnography (PSG). It is defined as the percentage of sleep time relative to total time spent in bed.
Postoperative Night 1
Number of awakenings after sleep onset assessed by polysomnography (PSG)
Prazo: Postoperative Night 1
Number of awakenings after sleep onset measured by polysomnography (PSG).
Postoperative Night 1
Total wake time assessed by polysomnography (PSG)
Prazo: Postoperative Night 1
Total duration of awakenings during sleep measured by polysomnography (PSG).
Postoperative Night 1
Proportion of each sleep stage assessed by polysomnography (PSG)
Prazo: Postoperative Night 1
Proportion of each sleep stage measured by polysomnography (PSG), including N1,N2,N3 and REM.
Postoperative Night 1
Serum levels of cortisol
Prazo: on the morning of postoperative day 1
Serum levels of cortisol were measured preoperatively and on the morning of postoperative day 1 and compared between the two groups.
on the morning of postoperative day 1
Movement Visual Analogue Scale (VAS) Pain Score
Prazo: Postoperative Day 1, Postoperative Day 2, Postoperative Day 3
Postoperative pain during movement assessed via the Visual Analogue Scale (VAS). Scores range from 0 to 10; higher scores indicate greater pain intensity.
Postoperative Day 1, Postoperative Day 2, Postoperative Day 3
Serum C-reactive protein (CRP) level
Prazo: Morning of postoperative day 1
Serum concentration of C-reactive protein (CRP).
Morning of postoperative day 1
Serum interleukin-6 (IL-6) level
Prazo: Morning of postoperative day 1
Serum concentration of interleukin-6 (IL-6).
Morning of postoperative day 1

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

General Hospital of Ningxia Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de janeiro de 2027

Conclusão do estudo (Estimado)

28 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

31 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de julho de 2026

Primeira postagem (Real)

31 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RMZ on postoperative sleep

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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