New sedative may prevent Post-Surgery confusion in seniors
NCT ID NCT06674226
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study tests whether ciprofol, a new sedative, can lower the risk of postoperative delirium (sudden confusion) in patients aged 65 and older after major chest surgery. About 214 participants will receive either ciprofol or the standard drug propofol during anesthesia. The goal is to see if ciprofol leads to fewer cases of delirium and better recovery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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225 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038, China
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The First Affiliated Hospital, Jinan University
Guangzhou, Guangdong, China
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The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050030, China
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The third Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
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Tongji Hospital
Wuhan, Hubei, 430030, China
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Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
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Xuanwu Hospital
Beijing, Beijing Municipality, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two sedatives, one question: can remimazolam shield the brain during aortic arch surgery?
- A heartbeat clue to Post-Surgery confusion in seniors?
- A simple eye mask might protect sleep and calm confusion after heart surgery
- Can a painkiller shield older hearts from Post-Surgery confusion?
- Could deep breaths before surgery ward off Post-Op confusion?
- Can surgery for stomach or esophageal cancer cloud the mind?