NCT01661907

Anesthesia-analgesia Methods and Postoperative Delirium

Completed NA Last updated 8 July 2020

What this trial tests

NA trial testing Combined Epi-GA/PCEA in Elderly in 1,800 participants. Completed in 24 June 2015.

Timeline

21 November 2011

Primary endpoint
25 May 2015

24 June 2015

Quick facts

Lead sponsor	Peking University First Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,800
Start date	21 November 2011
Primary completion	25 May 2015
Estimated completion	24 June 2015
Sites	1 location across China

Drugs / interventions tested

• Combined Epi-GA/PCEA
• GA/PCIA

Conditions studied

• Elderly — all drugs for Elderly →
• Epidural Anesthesia — all drugs for Epidural Anesthesia →
• General Anesthesia — all drugs for General Anesthesia →
• Major Surgery — all drugs for Major Surgery →

Sponsor

Peking University First Hospital

Who can join

Adults 60 to 90, any sex, with Elderly or Epidural Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for preventing delirium in hospitalised non-ICU patients.
   Siddiqi N, Harrison JK, Clegg A, Teale EA, et al · · 2016 · cited 248× · PMID 26967259 · DOI 10.1002/14651858.cd005563.pub3
2. Epidural local anaesthetics versus opioid-based analgesic regimens for postoperative gastrointestinal paralysis, vomiting and pain after abdominal surgery.
   Guay J, Nishimori M, Kopp S. · · 2016 · cited 85× · PMID 27419911 · DOI 10.1002/14651858.cd001893.pub2
3. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery.
   Guay J, Kopp S. · · 2016 · cited 49× · PMID 26731032 · DOI 10.1002/14651858.cd005059.pub4
4. Effects of two different anesthesia-analgesia methods on incidence of postoperative delirium in elderly patients undergoing major thoracic and abdominal surgery: study rationale and protocol for a multicenter randomized controlled trial.
   Li YW, Li HJ, Li HJ, Feng Y, et al · · 2015 · cited 10× · PMID 26459347 · DOI 10.1186/s12871-015-0118-5
5. Random forest algorithm for predicting postoperative delirium in older patients.
   Sheng W, Tang X, Hu X, Liu P, et al · · 2023 · cited 8× · PMID 38274882 · DOI 10.3389/fneur.2023.1325941
6. Application of XGBoost in the prediction of acute postoperative pain after major noncardiac surgery in older patients.
   Sun Y, Yu K, Du L, Hu X, et al · · 2025 · cited 1× · PMID 40856310 · DOI 10.1177/17448069251376199
7. Development of a machine learning algorithm model to predict intraoperative hypotension in elderly patients undergoing thoracic and abdominal surgeries.
   An Y, Liu P, Liu L, Hu X, et al · · 2026 · PMID 41852709 · DOI 10.1515/med-2026-1381
8. FADS1 contributes to anesthesia/surgery-induced cognitive impairment by aggravating omega-6 fatty acid metabolic disruption in aged mice.
   Chen Z, Wu Q, Ma J, Shi Y, et al · · 2026 · PMID 41673763 · DOI 10.1186/s12974-025-03678-y