このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Remimazolam for Postoperative Sleep in Elderly Patients

2026年9月2日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

84

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
    • Ningxia
      • Yinchuan、Ningxia、中国
        • 募集
        • General Hospital of Ningxia Medical University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Remimazolam (Group R)
Remimazolam was used for both anesthesia induction and maintenance
薬：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.
アクティブコンパレータ：Propofol (Group P)
Propofol was used for both anesthesia induction and maintenance.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Total sleep time (TST) on the first postoperative night
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Richards-Campbell Sleep Questionnaire (RCSQ) Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：Postoperative Night 1
Number of awakenings after sleep onset measured by polysomnography (PSG).
Postoperative Night 1
Total wake time assessed by polysomnography (PSG)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：Morning of postoperative day 1
Serum concentration of C-reactive protein (CRP).
Morning of postoperative day 1
Serum interleukin-6 (IL-6) level
時間枠：Morning of postoperative day 1
Serum concentration of interleukin-6 (IL-6).
Morning of postoperative day 1

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

General Hospital of Ningxia Medical University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月1日

一次修了 (推定)

2027年1月31日

研究の完了 (推定)

2027年2月28日

試験登録日

最初に提出

2026年5月31日

QC基準を満たした最初の提出物

2026年7月30日

最初の投稿 (実際)

2026年7月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月3日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RMZ on postoperative sleep

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する