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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
214
Xuanwu Hospital
Beijing, Beijing Municipality, China
RECRUITINGXuanwu Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital, Jinan University
Guangzhou, Guangdong, China
RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGTongji Hospital
Wuhan, Hubei, China
RECRUITINGThe third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGDrum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGIncidence of postoperative delirium
Incidence of delirium on the first to seventh day after surgery or on the day of discharge (whichever occurs first).
Time frame: up to the seventh day after surgery or on the day of discharge (whichever occurs first).
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
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
Hypotension is defined as invasive MAP\<65mmHg or \<80% of baseline value.
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).
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