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New sedative may prevent Post-Surgery confusion in seniors

NCT ID NCT06674226

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

225 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

Emergence Delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Drum Tower Hospital

    Nanjing, Jiangsu, 210000, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330038, China

  • The First Affiliated Hospital, Jinan University

    Guangzhou, Guangdong, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050030, China

  • The third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000, China

  • Tongji Hospital

    Wuhan, Hubei, 430030, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Xuanwu Hospital

    Beijing, Beijing Municipality, 100053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.