CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,800 enrolled
Drug / intervention
Combined Epi-GA/PCEA +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT01661907
NCT01661907N/ACompleted

Effects of Two Different Anesthesia-analgesia Methods on the Incidence of Postoperative Delirium: a Multicenter, Randomized Controlled Trial

Peking University First Hospital·interventional·Posted Aug 10, 2012·Updated Jul 8, 2020

In Brief

A clinical study evaluating Combined Epi-GA/PCEA and GA/PCIA for Elderly and 4 related conditions. Completed, enrolled 1,800 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartNov 21, 2011
Primary CompletionMay 25, 2015
Study CompletionJun 24, 2015
TodayJul 1, 2026
Enrollment to primary: 3.5 yearsPosted 13.9 years ago

Interventions

Combined Epi-GA/PCEAprocedure

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.

GA/PCIAprocedure

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.