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Remimazolam for Postoperative Sleep in Elderly Patients

2 de septiembre de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

84

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Porcelana
    • Ningxia
      • Yinchuan, Ningxia, Porcelana
        • Reclutamiento
        • General Hospital of Ningxia Medical University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Remimazolam (Group R)
Remimazolam was used for both anesthesia induction and maintenance
Droga: 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 activo: Propofol (Group P)
Propofol was used for both anesthesia induction and maintenance.
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total sleep time (TST) on the first postoperative night
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Richards-Campbell Sleep Questionnaire (RCSQ) Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Postoperative Night 1
Number of awakenings after sleep onset measured by polysomnography (PSG).
Postoperative Night 1
Total wake time assessed by polysomnography (PSG)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Morning of postoperative day 1
Serum concentration of C-reactive protein (CRP).
Morning of postoperative day 1
Serum interleukin-6 (IL-6) level
Periodo de tiempo: Morning of postoperative day 1
Serum concentration of interleukin-6 (IL-6).
Morning of postoperative day 1

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

General Hospital of Ningxia Medical University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2026

Finalización primaria (Estimado)

31 de enero de 2027

Finalización del estudio (Estimado)

28 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

31 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de julio de 2026

Publicado por primera vez (Actual)

31 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RMZ on postoperative sleep

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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