Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery: a Multicentre, Prospective, Single-blind, Randomized Controlled Study

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Xuanwu Hospital
RECRUITING
Beijing
Xuanwu Hospital
RECRUITING
Beijing
The third Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital, Jinan University
RECRUITING
Guangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Drum Tower Hospital
RECRUITING
Nanjing
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tongji Hospital
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Tianlong Wang
w_tl5595@hotmail.com
0086139 1052 5304
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 214
Treatments
Experimental: Ciprofol group
Interventions:~Drug:Ciprofol
Active_comparator: Propofol group
Drug:Propofol
Related Therapeutic Areas
Sponsors
Leads: Wang Tianlong
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Nanchang University, The First Hospital of Hebei Medical University, Tongji Hospital, The Third Xiangya Hospital of Central South University, Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov

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