Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery

Last updated: June 29, 2026
Sponsor: Wang Tianlong
Overall Status: Completed

Phase

4

Condition

Dementia

Treatment

Ciprofol

Propofol

Clinical Study ID

NCT06674226
Linyanshen[2024]201-002
  • Ages > 65
  • All Genders

Study Summary

There are many factors that make elderly patients prone to POD. On the basis of these factors, surgery and anesthesia can increase the incidence of POD in elderly patients. Deep depth of intraoperative anesthesia and persistent hypotension may increase the risk of POD occurrence in elderly patients. So far, no specific POD prevention method has been found. In recent years, a large number of studies on POD have brought forward more new views on its pathogenesis, prevention and treatment. There is insufficient evidence to recommend specific anesthetic agents and dosages to reduce the risk of POD in elderly patients, and only low-quality evidence to recommend propofol. At present, it is considered that the best way to reduce postoperative delirium is perioperative risk management, to evaluate high-risk patients or patients undergoing high-risk surgery as extensive as possible, and to quantify their risk of postoperative delirium. Effective measures include depth management of anesthesia, multi-modal analgesia management, and optimization of drug intervention.

Ciprofol is a class 1 innovative drug independently developed by China and with global independent intellectual property rights. Ciprofol has been widely used in anesthesiology and critical care medicine. The pre-market phase I-III and post-market data showed that during the induction and maintenance of general anesthesia, Ciprofol had less impact on hemodynamics and more stable anesthesia depth than propofol. Relevant studies have shown that Ciprofol can reduce the risk of hypotension, and can provide better brain oxygenation and more stable intraoperative hemodynamics than propofol. At present, the influence of different sedative drugs on POD incidence in elderly patients remains to be studied. Therefore, we will apply Ciprofol or propofol in elderly patients undergoing thoracic surgery to observe their influence on POD incidence and provide reference for clinical use.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥65 years old, gender unlimited;

  • Selective thoracoscopic lobectomy and segmental lung resection were performed, andthe estimated time of anesthesia (from the beginning of anesthesia to the end ofsurgery) was ≥2 hours;

  • ASA score is Grade I ~III; (Annex 1)

  • A BMI of 18.5 to 29.9 kg/m2 [BMI= weight (Kg)/height (m) 2] (2013 U.S. Guidelinesfor the Management of Overweight and Obesity in Adults);

  • Postoperative hospital stay more than 72 hours;

  • Ethical, patients voluntarily take the test and sign the informed consent.

Exclusion

Exclusion Criteria:

  • Emergency surgery; Hypovolemia, shock or coma;

  • In addition to general intravenous anesthesia, other anesthesia methods should becombined, such as inhalation anesthesia, epidural anesthesia, peripheral nerveblock, etc., but it is not necessary to exclude patients with local infiltration oflocal anesthetic incision;

  • Serious cardiovascular disease, including a history of myocardial infarction within 6 months, bradycardia (resting heart rate < 50 beats/min); Patients withhypertension whose blood pressure is not satisfactorily controlled (seated systolicblood pressure ≥160 mmHg during screening, and/or diastolic blood pressure ≥100 mmHgduring screening); Sitting systolic blood pressure ≤90 mmHg during the screeningperiod; A history of severe heart valve disease.

  • Abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN;

  • Abnormal renal function, urea or urea nitrogen ≥1.5×ULN, blood creatinine greaterthan the upper limit of normal;

  • Glycated hemoglobin (HbA1c) ≥ 8.5%, fasting blood glucose ≥180 mg/dl (10 mmol/L),blood glucose ≥270mg/dl (15mmol/L) 1 hour after meals, or blood glucose ≥216 mg/dl (12mmol/L) 2 hours after meals;

  • Patients with type I and type II expiratory failure

  • Preoperative anemia (Hb≤90 g/L), thrombocytopenia (PLT≤80×109/L), hypoproteinemia (Alb≤30 g/L);

  • A history of drug use and/or alcohol abuse within the 2 years prior to screening,with alcohol abuse being an average consumption of more than 2 units of alcohol perday (1 unit =360 mL beer or 150 mL of 45 mL liquor or wine with an alcoholconcentration of 40%);

  • Patients with neurological diseases (stroke, Alzheimer's disease, Parkinson'sdisease, mental illness, myasthenia grave, etc., within 6 months), psychiatricdiseases (schizophrenia, mania, bipolar disorder, insanity, etc.), long-term historyof taking psychiatric drugs and cognitive impairment (using the simple mental StateAssessment Form (MMSE scale (Annex 2));

  • Patients who take sedative sleeping drugs and antiepileptic drugs for a long time;

  • Allergic to the investigational drug or contraindicated;

  • Participated in other drug clinical trials as a subject within the last 3 months;

  • Patients who refused or were unable to cooperate with the study;

  • Other conditions that the investigator considers inappropriate to participate inthis study.

Study Design

Total Participants: 225
Treatment Group(s): 2
Primary Treatment: Ciprofol
Phase: 4
Study Start date:
December 23, 2024
Estimated Completion Date:
April 15, 2026

Study Description

This study was a prospective, single-blinded, randomized controlled study. Elderly patients (≥65 years old) who were to receive elective thoracoscopic lobectomy and pulmonary segmentation under general anesthesia and whose estimated time of anesthesia (from the beginning of anesthesia to the end of surgery) was ≥2 hours were enrolled into this study, and were randomly divided according to 1:1, namely the ciprofol group and the propofol group. Study data of patients were recorded before surgery, during surgery, 7 days after surgery or before discharge.Primary end point: Incidence of postoperative delirium(Incidence of delirium on the first to seventh day after surgery or to the day of discharge (whichever occurs first)).

Connect with a study center

  • Xuanwu Hospital

    Beijing, Beijing Municipality 100053
    China

    Site Not Available

  • Xuanwu Hospital

    Beijing 1816670, Beijing Municipality 2038349 100053
    China

    Active - Recruiting

  • The First Affiliated Hospital, Jinan University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050030
    China

    Site Not Available

  • Tongji Hospital

    Wuhan, Hubei 430030
    China

    Site Not Available

  • The third Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410008
    China

    Active - Recruiting

  • Drum Tower Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330038
    China

    Site Not Available

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