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| Name | Class |
|---|---|
| Xiangya Hospital of Central South University | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
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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.
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)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol group | Experimental | Interventions: Drug:Ciprofol |
|
| Propofol group | Active Comparator | Drug:Propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | 0.25mg/kg for anesthesia induction +0.25~1.5 mg/kg/h for maintenance |
| |
| 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). |
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tianlong Wang, Doctor | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | Beijing Municipality | 100053 | China | ||
| The First Affiliated Hospital, Jinan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40829819 | Derived | 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. |
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After the article is published, contact the corresponding author to obtain
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| The First Affiliated Hospital of Nanchang University |
| OTHER |
| Tongji Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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| Propofol |
| Drug |
1.0mg/kg for induction +1 ~ 6mg/kg/h for maintenace |
|
| 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). |
| Guangzhou |
| Guangdong |
| China |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050030 | China |
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
| The third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| Drum Tower Hospital | Nanjing | Jiangsu | 210000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330038 | China |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |