Postoperative Delirium (POD)Phase 4NCT06674226
Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery
A Phase 4 study testing Ciprofol and Propofol in people with Postoperative Delirium (POD), run by Wang Tianlong at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Ciprofol and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 8 sitesChina
- Study dates
- 23 Dec 2024to 15 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
The third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The First Affiliated Hospital, Jinan University
Guangzhou, Guangdong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038
Drum Tower Hospital
Nanjing, Jiangsu, 210000
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050030
Tongji Hospital
Wuhan, Hubei, 430030
About this study
Official title: 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.
Read the 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)).
- Conditions
- Postoperative Delirium (POD)
- Being tested
- Ciprofol, Propofol
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
0.25mg/kg for anesthesia induction ＋0.25~1.5 mg/kg/h for maintenance
PropofolDrug
1.0mg/kg for induction ＋1 ~ 6mg/kg/h for maintenace
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group | Experimental | Interventions:
Drug:Ciprofol Receives: Drug: Ciprofol |
| Propofol group | Active comparator | Drug:Propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Incidence of delirium on the first to seventh day after surgery or on the day of discharge (whichever occurs first).
Measured: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Secondary outcomes (9)
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
Measured: from the onset of extubation to departure of the PACU
The incidence of combined adverse events during induction and maintenance of anesthesia;
Measured: During the intervention
Duration of intraoperative hypotension
Hypotension is defined as invasive MAP<65mmHg or <80% of baseline value.
Measured: During the intervention
Minimum mean intraoperative arterial pressure
Measured: During the intervention
Duration of WLi < 40
Measured: During the intervention
Other adverse events identified during the follow-up period, except POD
Measured: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Length of stay
Measured: Perioperatively
First exhaust time
Measured: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Postoperative first time to taking food
Measured: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start23 Dec 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang Tianlong
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Nanchang University, Tongji Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor-investigator, Wang Tianlong, Xuanwu Hospital, Beijing
- Investigators
- Tianlong Wang, Doctor, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674226
- Sponsor's protocol ID
- Linyanshen[2024]201-002
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 40829819
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery: a Multicentre, Prospective, Single-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06674226
- Acronym / sponsor ID
- Linyanshen[2024]201-002
- Conditions
- Postoperative Delirium (POD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Wang TianlongUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Nanchang University, Tongji Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group | Experimental | Drug: CiprofolInterventions: Drug:Ciprofol |
| Propofol group | Active comparator | Drug: PropofolDrug:Propofol |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofol0.25mg/kg for anesthesia induction ＋0.25~1.5 mg/kg/h for maintenance | Drug | Ciprofol group |
| Propofol1.0mg/kg for induction ＋1 ~ 6mg/kg/h for maintenace | Drug | Propofol group |
Primary outcome
Incidence of postoperative delirium
Time frame: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Incidence of delirium on the first to seventh day after surgery or on the day of discharge (whichever occurs first).
9 secondary outcomes
Incidence of Emergence delirium
Time frame: from the onset of extubation to departure of the PACU
The incidence of combined adverse events during induction and maintenance of anesthesia;
Time frame: During the intervention
Duration of intraoperative hypotension
Time frame: During the intervention
Minimum mean intraoperative arterial pressure
Time frame: During the intervention
Duration of WLi < 40
Time frame: During the intervention
Other adverse events identified during the follow-up period, except POD
Time frame: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Length of stay
Time frame: Perioperatively
First exhaust time
Time frame: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Postoperative first time to taking food
Time frame: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 40829819Hong 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianlong Wang, Doctor principal investigator
Xuanwu Hospital, Beijing
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Propofol in people with Postoperative Delirium (POD), run by Wang Tianlong at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: up to the seventh day after surgery or on the day of discharge (whichever occurs first).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.