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

29 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

105

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Expérimental: 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
Comparateur actif: Normal Saline Group(Group N)
received an equivalent volume of normal saline.
Normal Saline Group (Group N) received an equivalent volume of normal saline.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of delirium at 30 minutes postoperatively and on postoperative days 1-3
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2025

Achèvement primaire (Réel)

1 février 2026

Achèvement de l'étude (Réel)

1 février 2026

Dates d'inscription aux études

Première soumission

11 avril 2026

Première soumission répondant aux critères de contrôle qualité

29 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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