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Effects of Epidural Anesthesia and Analgesia on Early Postoperative Delirium and Outcomes in Elderly Patients After Surgery: A Multi-central, Randomized Controlled Trial

Effects of two different anesthesia-analgesia methods on the incidence of postoperative delirium in elderly patients: a multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000543
Enrollment
Unknown
Registered
2009-09-21
Start date
2011-11-21
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Elderly patients (age range 60-90 years); (2) Scheduled to undergo noncardiac thoracic or abdominal surgery with an expected duration of 2 hours or longer. For those who undergo thoracoscopic or laparoscopic surgery, the expected length of incision must be 5 centimeters or more; (3) Agree to receive patient-controlled postoperative analgesia.

Exclusion criteria

Exclusion criteria: (1) Refuse to participate in the study; (2) Previous history of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier or end-stage disease; (3) History of myocardial infarction or stroke within 3 months before surgery; (4) Any contraindication to epidural anesthesia and analgesia, including abnormal vertebral anatomy, previous spinal trauma or surgery, severe chronic back pain, coagulation disorder (prothrombin time or activated partial prothrombin time longer than 1.5 times of the upper limit of normal, or platelet count of less than 80 × 10^9/L), local infection near the site of puncture, and severe sepsis; (5) Severe heart dysfunction (New York Heart Association functional classification 3 or above), hepatic insufficiency (Child-Pugh grades C), or renal insufficiency (serum creatinine of 442 µmol/L or above, with or without serum potassium of 6.5 mmol/L or above, or requirement of renal replacement therapy); (6) Any other conditions that were considered unsuitable for study participation; (7) Allergic to drugs involved in the protocol. From 2011-11-21 To 2015-05-25

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium;

Secondary

MeasureTime frame
ICU admission after surgery;APACHE II score at ICU admission;Duration of Mechanical Ventilation in ICU;Length of ICU stay;Time to fluid/food intake;Length of stay in hospital after surgery;All-cause 30-day mortality;Non-delirium complications within 30 days after surgery;Intensity of postoperative pain;Time to the first onset of delirium;ICU admission with endotracheal intubation;

Countries

China

Contacts

Public ContactDongxin Wang

Peking University First Hospital

wangdongxin@hotmail.com+86 13910731903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026