Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
Condition: Postoperative Cognitive Dysfunction; Postoperative Delirium
MeSH terms: Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether postoperative analgesia pump continuous
      infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and
      Postoperative cognitive dysfunction.
    

Detailed description: 
      1. collection of cases: This trail is approved by Hospital Ethics Committee, and patients
           who participated in the study signed the informed consent. The subject will select 300
           elder patients (age ≥60 years) routine tumor surgery, American Society of
           Anesthesiologists classificationⅠ-Ⅲ. Preoperative liver and kidney function, blood
           electrolytes were in the normal range.

        2. Case group: Selected cases divided into the right dexmedetomidine group and control
           group by computer randomly, 150 patients in each group. Dexmedetomidine group (A group)
           analgesia pump formula is: 3 ug/kg sufentanil and 3 ug/kg dexmedetomi-dine, with 0.9%
           saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: 3
           ug/kg sufentanil, with 0.9% saline diluted to 150ml. Two group with the same anesthesia
           program.

        3. Our primary outcome was the 7-day incidence of postoperative delirium assessed by
           CAM-ICU twice daily (8 a.m. and 8 p.m.) and supplemented with a review of medical and
           nursing records. The assessment was carried out by investigators who had been trained
           prior to the trial and were unaware of the group assignment.All investigators and
           patients were unknown of experiments and results. The four clinical criteria for CAM-ICU
           are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3)
           altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by
           the appearance of both features 1 and 2, with at least one of features 3 or 4. RASS was
           used to measure sedation or agita-tion prior to testing delirium. If the patient was
           deeply sedated or unable to fall asleep (RASS - 4 or - 5), delirium assessment was
           halted; if RASS score was of - 3 or above, delirium was evaluated by CAM-ICU.
    

Intervention name(s): Dexmedetomidine; Sufentanyl; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.; Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.; Saline is used to dilute other drugs
Other intervention name(s): Dexmedetomidine Hydrochloride Injection; Sufentanil Citrate Injection; normal saline,physiological saline,NS
Intervention MeSH terms: Sufentanil; Dexmedetomidine; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention