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

NCT07569614 | Completed

• 1 other identifier: （2025）Ethical Review L No.80
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium (POD); Thoracoscopic Surgery; Dexmedetomidine; Remimazolam Besylate

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium at 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

Study Arms (3)

Dexmedetomidine grop(Group D):

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

Remimazolam besylate grop (Group R)

EXPERIMENTAL

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.

Drug: Remimazolam Besylate

Normal Saline Group(Group N)

ACTIVE COMPARATOR

received an equivalent volume of normal saline.

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

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):

Normal Saline DRUG

Normal Saline Group (Group N) received an equivalent volume of normal saline.

Normal Saline Group(Group N)

Remimazolam Besylate DRUG

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

Remimazolam besylate grop (Group R)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

First Affiliated Hospital of Kunming Medical University Kunming

Kunming, Yunnan, 6500000, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person responsible for grouping; Data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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. Remimazolam group(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. Normal Saline Group(Group N ):received an equivalent volume of normal saline.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)