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Comparative Effects of Remimazolam Tosylate and Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery.

29 aprile 2026 aggiornato da: Jinqiao Qian, First Affiliated Hospital of Kunming Medical University

Comparative Effects of Remimazolam Tosylate and Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial

Postoperative delirium (POD) is a common acute brain dysfunction in the perioperative period, characterized by acute fluctuations in attention, consciousness, and cognition, typically occurring early after surgery. POD is closely associated with prolonged hospital stay, increased complications, delayed recovery, and higher mortality .

POD has multifactorial risk factors spanning preoperative, intraoperative, and postoperative phases. Its pathophysiology involves neuroinflammation, oxidative stress, blood-brain barrier dysfunction, and neurotransmitter imbalance . Advanced age, baseline cognitive impairment, infection, and malnutrition increase POD risk . Intraoperative hypotension, benzodiazepine exposure, and other anesthetic factors may also contribute .

Elderly patients have higher anesthesia risk due to age-related physiological decline. Cardiovascular reserve decreases with age, causing hemodynamic instability, especially during one-lung ventilation in thoracoscopic surgery . Among patients over 70 undergoing thoracoscopic lobectomy, 35.7% develop pulmonary complications; ASA grade ≥III, one-lung ventilation time, smoking history, and COPD are independent risk factors . Additionally, reduced hepatic and renal function slow anesthetic metabolism, increasing drug accumulation and delayed emergence .

Video-assisted thoracoscopic surgery (VATS) offers reduced trauma, faster recovery, and lower complication rates compared to open surgery . VATS shows clinical value in lung cancer and mediastinal tumors . Uniportal VATS allows faster recovery of pulmonary function (VC, FVC, TLC) and lower inflammatory markers (CRP, PCT, TNF-α) . However, caution is needed in elderly patients .

Despite reduced surgical trauma, elderly VATS patients may still develop POD. Anesthetic drugs, surgical stress, poor pain management, and neuroinflammation are key contributing factors . Therefore, optimizing perioperative anesthesia, maintaining hemodynamic stability, and reducing unnecessary sedative-analgesic loads are important strategies to lower POD risk.

Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with advantages in sedation, analgesia, and neuroprotection . It activates central α2-receptors, causing hyperpolarization of noradrenergic neurons and reducing norepinephrine release, producing sympatholytic effects without significant respiratory depression . It also has anti-inflammatory properties that may help prevent POD . Perioperative dexmedetomidine may reduce POD risk by alleviating stress, improving sleep-like sedation, and reducing opioid requirements . However, it can cause hypotension and bradycardia, requiring careful dosing in elderly patients .

Remimazolam tosilate is a newer ultra-short-acting benzodiazepine with rapid onset, fast metabolism, and mild circulatory depression. Its potential advantages in elderly and hemodynamically compromised patients are increasingly recognized, but its effect on POD remains inconclusive.

In summary, elderly VATS patients are at high risk for POD. Dexmedetomidine has preventive evidence but is limited by hypotension and bradycardia. Remimazolam may offer a smoother sedation alternative, but direct comparative evidence is lacking. This study aims to compare remimazolam versus dexmedetomidine on POD and perioperative recovery, providing evidence for individualized anesthesia management in elderly VATS patients.

Panoramica dello studio

Descrizione dettagliata

To explore whether toremazolam can improve postoperative delirium in patients undergoing thoracoscopic surgery. The purpose and significance of this study are to compare the effects of the two on postoperative delirium in patients undergoing thoracoscopic surgery, in order to provide new ideas for preventing postoperative delirium. Select patients who underwent elective general anesthesia and thoracoscopic surgery at the First Affiliated Hospital of Kunming Medical University from April 2025 to February 2026. Complete relevant examinations before the operation and exclude patients who do not meet the inclusion criteria. Record the patients' preoperative age, gender, and ASA classification. The patients were divided into three groups: N, D, and R. The D group was given 1 microgram/kg of dexmedetomidine as a loading dose and 0.4 microgram/kg/h for maintenance until 30 minutes before the end of the surgery; the R group was given 0.2 mg/kg of toremazolam in addition to the induction anesthesia, and 0.3-0.5 mg/kg/h of toremazolam was pumped after intubation until 30 minutes before the end of the surgery. The N group was given an equal volume of normal saline as the content and purpose of the study until 30 minutes before the end of the surgery. Record the postoperative extubation time, PACU stay time, and record the adverse reactions (pain, agitation during awakening) and their incidence rates. The definition of extubation time is the time from the cessation of anesthesia to the patient removing the double-lumen bronchial tube; the hospital stay is the time from the day of the surgery to the patient's discharge. Finally, the collected data will be statistically analyzed and compared. Research objective: To confirm that toremazolam tartrate can effectively prevent the occurrence of postoperative delirium in elderly patients undergoing thoracoscopic surgery.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

105

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Yunnan
      • Kunming, Yunnan, Cina, 6500000
        • First Affiliated Hospital of Kunming Medical University Kunming

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥ 60 years;
  • BMI: 18.5-23.9 kg/m²;
  • ASA grade II-III;
  • Preoperative MMSE score ≥ 25;
  • Signed informed consent before surgery.

Exclusion Criteria:

  • Recent history of sedative, analgesic, or opioid use;
  • Severe hypertension or significant hepatic or renal insufficiency;
  • Allergy to the study medications;
  • Alzheimer's disease or acute phase of mental illness;
  • History of chronic pain or receipt of analgesic therapy;
  • Hearing/visual impairment with communication difficulties.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Dexmedetomidine grop(Group D):
received a loading dose of dexmedetomidine at 0.67 μg/kg 10 minutes before surgery, followed by continuous infusion at 0.4 μg/kg/h until 30 minutes before the end of surgery.
Dexmedetomidine grop(Group D):received a loading dose of dexmedetomidine at 0.67 μg/kg 10 minutes before surgery, followed by continuous infusion at 0.4 μg/kg/h until 30 minutes before the end of surgery.
Sperimentale: Remimazolam besylate grop (Group R)
received remimazolam besylate at 0.2 mg/kg during the induction of anesthesia, followed by continuous infusion at 0.3-0.5 mg/kg/h until 30 minutes before the end of surgery.
Remimazolam besylate grop (Group R):received remimazolam besylate at 0.2 mg/kg during the induction of anesthesia, followed by continuous infusion at 0.3-0.5 mg/kg/h until 30 minutes before the end of surger
Comparatore attivo: Normal Saline Group(Group N)
received an equivalent volume of normal saline.
Normal Saline Group (Group N) received an equivalent volume of normal saline.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of delirium at 30 minutes postoperatively and on postoperative days 1-3
Lasso di tempo: 30 minutes postoperatively and on postoperative days 1-3
POD assessed with the 3-minute Diagnostic Interview for CAM (3D-CAM) at 30 min after surgery and on postoperative days 1-3.
30 minutes postoperatively and on postoperative days 1-3

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2025

Completamento primario (Effettivo)

1 febbraio 2026

Completamento dello studio (Effettivo)

1 febbraio 2026

Date di iscrizione allo studio

Primo inviato

11 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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