Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Delirium is a frequently occurred cerebral complication in elderly patients after surgery, and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be one of the most important risk factors of postoperative delirium. Previous studies showed that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion improved the quality of sleep and decreased the incidence of delirium. The investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine supplemented analgesia can also decrease the incidence of delirium, possibly by improving sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly patients after cancer surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborators: Affiliated Hospital of Hebei University; Beijing Chao Yang Hospital; Beijing Ditan Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Tsinghua Chang Gung Hospital; Guizhou Provincial People's Hospital; Peking University International Hospital; Qingdao Municipal Hospital; Shanxi Provincial Cancer Hospital; The Second Affiliated Hospital of Air Force Medical University; The Third Xiangya Hospital of Central South University; Tianjin Hospital of ITCWM-Nankai Hospital; Zhongda Hospital Southeast University
• Treatments: Analgesics; Dexmedetomidine; Morphine

Criteria

Inclusion Criteria:

• Age >= 65 years, < 90 years;

• Scheduled to undergo surgery for primary solid organ cancer under general anesthesia, with an expected duration of surgery >=2 hours;

• Planned to use patient-controlled intravenous analgesia after surgery;

• Provide written informed consent.

Exclusion Criteria:

• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;

• Preoperative radio- or chemotherapy;

• Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;

• Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or a STOP-Bang score >= 3);

• Brain trauma or neurosurgery;

• Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;

• Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction (requirement of renal replacement therapy before surgery);

• ASA classification >= IV.