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

NCT06674226 | Recruiting Phase 4

• 1 other identifier: Linyanshen[2024]201-002
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Postoperative Delirium (POD)

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Incidence of delirium on the first to seventh day after surgery or on the day of discharge (whichever occurs first).

  up to the seventh day after surgery or on the day of discharge (whichever occurs first).

Secondary Outcomes (9)

• Incidence of Emergence delirium

  from the onset of extubation to departure of the PACU

• The incidence of combined adverse events during induction and maintenance of anesthesia;

  During the intervention

• Duration of intraoperative hypotension

  During the intervention

• Minimum mean intraoperative arterial pressure

  During the intervention

• Duration of WLi < 40

  During the intervention

Study Arms (2)

Ciprofol group

EXPERIMENTAL

Interventions: Drug:Ciprofol

Drug: Ciprofol

Propofol group

ACTIVE COMPARATOR

Drug:Propofol

Drug: Propofol

Interventions

Ciprofol DRUG

0.25mg/kg for anesthesia induction ＋0.25\~1.5 mg/kg/h for maintenance

Ciprofol group

Propofol DRUG

1.0mg/kg for induction ＋1 \~ 6mg/kg/h for maintenace

Propofol group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years old, gender unlimited;
• Selective thoracoscopic lobectomy and segmental lung resection were performed, and the estimated time of anesthesia (from the beginning of anesthesia to the end of surgery) 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. Guidelines for 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.

You may not qualify if:

• Emergency surgery; Hypovolemia, shock or coma;
• In addition to general intravenous anesthesia, other anesthesia methods should be combined, such as inhalation anesthesia, epidural anesthesia, peripheral nerve block, etc., but it is not necessary to exclude patients with local infiltration of local anesthetic incision;
• Serious cardiovascular disease, including a history of myocardial infarction within 6 months, bradycardia (resting heart rate \< 50 beats/min); Patients with hypertension whose blood pressure is not satisfactorily controlled (seated systolic blood pressure ≥160 mmHg during screening, and/or diastolic blood pressure ≥100 mmHg during screening); Sitting systolic blood pressure ≤90 mmHg during the screening period; 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 greater than 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 per day (1 unit =360 mL beer or 150 mL of 45 mL liquor or wine with an alcohol concentration of 40%);
• Patients with neurological diseases (stroke, Alzheimer's disease, Parkinson's disease, mental illness, myasthenia grave, etc., within 6 months), psychiatric diseases (schizophrenia, mania, bipolar disorder, insanity, etc.), long-term history of taking psychiatric drugs and cognitive impairment (using the simple mental State Assessment 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 in this study.

Sponsors & Collaborators

• Wang Tianlong: lead
• Xiangya Hospital of Central South University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• The First Hospital of Hebei Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Tongji Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (9)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

The First Affiliated Hospital, Jinan University

Guangzhou, Guangdong, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050030, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

The third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330038, China

RECRUITING

Related Publications (1)

• Hong P, Liu Q, Ouyang W, Luo A, Wang E, Gu X, Wang L, Chen S, Wang H, Xiao W, Wang T. Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study. BMJ Open. 2025 Aug 19;15(8):e105818. doi: 10.1136/bmjopen-2025-105818.

  PMID: 40829819 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

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)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tianlong Wang, Doctor

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianlong Wang

CONTACT

0086139 1052 5304; w_tl5595@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the article is published, contact the corresponding author to obtain

Locations

CN (9)