Anesthesia-analgesia Methods and Postoperative Delirium

NCT01661907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2020-07-08

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01661907 on ClinicalTrials.gov