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NCT Number: NCT07569614

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Kunming Medical University Kunming

Kunming, Yunnan, 6500000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

normal saline

Drug

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

Primary outcomes

  1. Incidence of delirium at 30 minutes postoperatively and on postoperative days 1-3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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