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

Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery: a Multicentre, Prospective, Single-blind, Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium (POD)
• Intervention / Treatment: Drug: Ciprofol; Drug: Propofol

Detailed 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)).

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tianlong Wang; Phone Number: 0086139 1052 5304; Email: w_tl5595@hotmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital
      • Contact: Tianlong Wang; Phone Number: 008613910525304; Email: w_tl5595@hotmail.com
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital, Jinan University
      • Principal Investigator: Hao Wang
      • Contact: Hao Wang, Doctor; Phone Number: 8615521329479; Email: haowang@jnu.edu.cn
  • Hebei
    • Shijiazhuang, Hebei, China, 050030
      • Recruiting
      • The First Hospital of Hebei Medical University
      • Principal Investigator: Li Wang
      • Contact: Li Wang, Doctor; Phone Number: 008613933170139; Email: lw79812@163.com
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Ailin Luo, Doctor; Phone Number: 008613507122565; Email: alluo@tjh.tjmu.edu.cn
      • Principal Investigator: Ailin Luo, Doctor
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: E Wang, Doctor; Phone Number: 008618874889950; Email: ewang324@hotmail.com
      • Principal Investigator: E Wang, Doctor
    • Changsha, Hunan, China, 410000
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Principal Investigator: Wen Ouyang
      • Contact: Wen Ouyang, Doctor; Phone Number: 008613974934441; Email: ouyangwen133@VIP.sina.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Drum Tower Hospital
      • Contact: Xiaoping Gu, Doctor; Phone Number: 008618913346697; Email: 13813996903@126.com
      • Principal Investigator: Xiaoping Gu, Doctor
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Shibiao Chen, Doctor; Phone Number: 008613870982918; Email: chenlaoshi1111@163.com
      • Principal Investigator: Shibiao Chen, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol group; Interventions: Drug:Ciprofol	Drug: Ciprofol; 0.25mg/kg for anesthesia induction ＋0.25~1.5 mg/kg/h for maintenance
Active Comparator: Propofol group; Drug:Propofol	Drug: Propofol; 1.0mg/kg for induction ＋1 ~ 6mg/kg/h for maintenace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Emergence delirium	Delirium occurred from the onset of extubation to departure of the PACU was assessed using the CAM-ICU scale by a trained accessor who was not aware of this grouping	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	Hypotension is defined as invasive MAP<65mmHg or <80% of baseline value.	During the intervention
Minimum mean intraoperative arterial pressure		During the intervention
Duration of WLi < 40		During the intervention
Other adverse events identified during the follow-up period, except POD		up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Length of stay		Perioperatively
First exhaust time		up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Postoperative first time to taking food		up to the seventh day after surgery or on the day of discharge (whichever occurs first).

Collaborators and Investigators

• Sponsor: Wang Tianlong
• Collaborators: The First Affiliated Hospital of Nanchang University; Xiangya Hospital of Central South University; Tongji Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The Third Xiangya Hospital of Central South University; The First Hospital of Hebei Medical University
• Investigators: Principal Investigator: Tianlong Wang, Doctor, Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol
• Other Study ID Numbers: Linyanshen[2024]201-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After the article is published, contact the corresponding author to obtain
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes