Anesthesia-analgesia Methods and Postoperative Delirium
NCT01661907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800
Last updated 2020-07-08
Summary
Postoperative delirium is a common complication in elderly patients after surgery. Its occurrence is associated with worse outcomes. The pathophysiology of delirium remains poorly understood. However, an universal phenomenon is that delirium frequently occurs in elderly patients after major complicated surgery, but is rarely seen after minor ambulatory surgery (such as cataract surgery). This indicates that stress response produced by surgery might have an important role in the pathogenesis of delirium. It has been reported that, when compared with general anesthesia and postoperative intravenous analgesia, neuraxial anesthesia and analgesia reduced the occurrence of postoperative complications and mortality in high risk patients. Combined epidural-general anesthesia is frequently used in clinical practice. This anesthetic method provides advantages of both epidural and general anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus by neuraxial blockade during and after surgery, and allows patients to endure long-duration surgery without any awareness. The investigators hypothesize that combined epidural-general anesthesia and postoperative epidural analgesia can decrease the incidence of delirium in elderly patients after major surgery when compared with general anesthesia alone and postoperative intravenous analgesia.
Conditions
- Elderly
- Epidural Anesthesia
- General Anesthesia
- Major Surgery
- Postoperative Delirium
Interventions
- PROCEDURE
-
Combined Epi-GA/PCEA
An epidural catheter will be placed before the induction of general anesthesia. General anesthesia will be induced and maintained as in the control group, with the addition of epidural anesthesia which will be maintained with the use of 0.375%-0.5% ropivacaine during surgery. Patient-controlled epidural analgesia will be provided after surgery.
- PROCEDURE
-
GA/PCIA
General anesthesia will be induced with midazolam, propofol, sufentanil and rocuronium. Anesthesia will be maintained with either intravenous (propofol), inhalational (sevoflurane with or without nitrous oxide), or combined intravenous-inhalational anesthetics. Additional opioids (remifentanil, sufentanil, fentanyl, or morphine) and muscle relaxant (rocuronium, atracurium, or cisatracurium) will be administered when deemed necessary by the attending anesthesiologists. Patient-controlled intravenous analgesia will be provided after surgery.
Sponsors & Collaborators
-
Peking University People's Hospital
collaborator OTHER -
Peking University Third Hospital
collaborator OTHER -
Beijing Hospital
collaborator OTHER_GOV -
Beijing Shijitan Hospital, Capital Medical University
collaborator OTHER -
Peking University First Hospital
lead OTHER
Principal Investigators
-
Dong-Xin Wang, MD, PhD · Peking University First Hopital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-21
- Primary Completion
- 2015-05-25
- Completion
- 2015-06-24
Countries
- China
Study Locations
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