Actively Recruiting

Phase 4
Age: 65Years +
All Genders
ID06674226

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

Led by Wang Tianlong · Updated on 2026-04-28

214

Participants Needed

9

Research Sites

N/A

Total Duration

On this page

Sponsors

W

Wang Tianlong

Lead Sponsor

X

Xiangya Hospital of Central South University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying postoperative delirium (POD) in elderly patients undergoing major thoracic surgery to understand how different anesthesia drugs might affect its occurrence. POD is common in older adults after surgery, and factors like deep anesthesia and low blood pressure may increase its risk. This study compares the effects of two anesthetic drugs, Ciprofol and Propofol, on the incidence of POD to provide clinical guidance for anesthesia management in elderly patients. The study is a prospective, single-blinded, randomized controlled trial involving patients aged 65 and older scheduled for elective thoracoscopic lobectomy or lung segment resection lasting at least 2 hours. Participants are randomly assigned to receive either Ciprofol (0.25 mg/kg induction, 0.25–1.5 mg/kg/h maintenance) or Propofol (1.0 mg/kg induction, 1–6 mg/kg/h maintenance) during anesthesia. Researchers will monitor patients during surgery and for 7 days after or until discharge to observe the effects on POD and other related outcomes. Participants will undergo evaluations before surgery, during anesthesia, and postoperatively including assessments for delirium from day 1 to day 7 or discharge. The study will also record adverse events, intraoperative blood pressure, anesthesia depth, length of hospital stay, and recovery milestones like first bowel movement and time to eating. Data collection aims to assess the safety and influence of the two anesthetics on postoperative delirium and overall outcomes in elderly thoracic surgery patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older, any gender
  • Scheduled for elective thoracoscopic lobectomy or lung segment resection with anesthesia duration of 2 hours or more
  • ASA physical status classification Grade I to III
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
  • Expected postoperative hospital stay longer than 72 hours
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Emergency surgery, hypovolemia, shock, or coma
  • Use of anesthesia methods other than general intravenous anesthesia except local anesthetic infiltration
  • Serious cardiovascular diseases including recent myocardial infarction within 6 months, bradycardia with resting heart rate less than 50 bpm, uncontrolled hypertension, or severe heart valve disease
  • Abnormal liver function with AST/ALT ≥ 2.5 times upper limit of normal or total bilirubin ≥ 1.5 times upper limit
  • Abnormal kidney function with urea or creatinine above normal limits
  • Poorly controlled diabetes with HbA1c ≥ 8.5% or high blood glucose levels
  • Type I or II respiratory failure
  • Preoperative anemia, thrombocytopenia, or low blood protein levels
  • History of drug or alcohol abuse within 2 years
  • Neurological or psychiatric diseases, recent stroke, cognitive impairment, or long-term psychiatric drug use
  • Long-term use of sedative sleeping or antiepileptic drugs
  • Allergy or contraindication to study drugs
  • Participation in other drug trials within last 3 months
  • Inability or refusal to cooperate with study procedures
  • Other investigator-determined reasons making participation inappropriate

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo general anesthesia using either Ciprofol or Propofol during elective thoracoscopic lobectomy or lung segment resection lasting at least 2 hours.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 7 days post-surgery or until discharge

Participants are monitored for postoperative delirium and other outcomes for up to 7 days after surgery or until discharge, whichever occurs first.

Daily visits for up to 7 days or until discharge

Trial Site Locations

Total: 9 locations

1

Xuanwu Hospital

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

2

Xuanwu Hospital

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

3

The First Affiliated Hospital, Jinan University

Guangzhou, Guangdong, China

Actively Recruiting

4

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050030

Actively Recruiting

5

Tongji Hospital

Wuhan, Hubei, China, 430030

Actively Recruiting

6

The third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410000

Actively Recruiting

7

Xiangya Hospital of Central South University

Changsha, Hunan, China, 410008

Actively Recruiting

8

Drum Tower Hospital

Nanjing, Jiangsu, China, 210000

Actively Recruiting

9

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330038

Actively Recruiting

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Research Team

T

Tianlong Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Pu Hong, Qian Liu, Wen Ouyang...

https://pubmed.ncbi.nlm.nih.gov/40829819