Anesthesia-analgesia Methods and Postoperative Delirium

NCT01661907 | Completed DMC

• 2 other identifiers: PUCRP201101ChiCTR-TRC-09000543
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elderly; Epidural anesthesia; General anesthesia; Major surgery; Postoperative delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Patients will be visited twice daily during the first seven days after surgery (between 08:00 h and 10:00 h, and between 18:00 h and 20:00 h). Delirium will be assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The incidence is calculated as percentage of patients who develope any episode of delirium during that period.

  During the first 7 days after surgery.

Secondary Outcomes (11)

• Intensive care unit (ICU) admission after surgery

  During the day of surgery.

• APACHE II score at ICU admission

  Within 24 hours after surgery.

• The percentage of ICU admission with endotracheal intubation

  During the day of surgery.

• The duration of Mechanical Ventilation in ICU

  Up to 30 days after surgery.

• The Length of ICU stay

  Up to 30 days after surgery.

Other Outcomes (3)

• Serum cortisol concentration (substudy)

  Blood samples will be collected from selected patients before surgery, and in the morning of the 1st and 3rd day after surgery.

• Serum IL-6 concentration (substudy)

  Blood samples will be collected from selected patients before surgery, and in the morning of the 1st and 3rd day after surgery.

• Serum IL-8 concentration (substudy)

  Blood samples will be collected from selected patients before surgery, and in the morning of the 1st and 3rd day after surgery.

Study Arms (2)

Combined Epi-GA/PCEA

EXPERIMENTAL

Patients assigned to this group (experimental group) will receive combined epidural-general anesthesia (combined Epi-GA) and patient-controlled epidural analgesia (PCEA). An epidural catheter will be placed before anesthesia induction. General anesthesia will be induced and maintained in the same manner as in the control group, with the addition of a continuous infusion or intermittent boluses of 0.375%-0.5% ropivacaine given through the epidural catheter for analgesia maintenance. Patient-controlled epidural analgesia will be provided for postoperative analgesia (established with 0.12% ropivacaine and 0.5 μg/mL sufentanil in 250 mL normal saline, programmed to deliver a 2-mL bolus with a lockout interval of 20 minutes and a background infusion of 4 mL/hr).

Procedure: Combined Epi-GA/PCEA

GA/PCIA

ACTIVE COMPARATOR

Patients assigned to this group (control group) will receive general anesthesia (GA) and patient-controlled intravenous analgesia (PCIA). General anesthesia will be induced with midazolam, sufentanil, propofol and rocuronium. Anesthesia will then be maintained by inhalation of sevoflurane with or without nitrous oxide, and/or continuous intravenous infusion of propofol. Sufentanil and rocuronium will be given when needed. Patient-controlled intravenous analgesia will be provided for postoperative analgesia (established with 50 mg morphine in 100 mL normal saline, programmed to deliver a 2-mL bolus with a 6-10 minutes lockout interval and a 1 mL/hr background infusion).

Procedure: GA/PCIA

Interventions

Combined Epi-GA/PCEA PROCEDURE

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.

Combined Epi-GA/PCEA

GA/PCIA PROCEDURE

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.

GA/PCIA

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elderly patients (age range 60-90 years);
• 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;
• agree to receive patient-controlled postoperative analgesia.

You may not qualify if:

• previous history of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier or end-stage disease;
• history of myocardial infarction within 3 months before surgery;
• 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;
• 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); or
• any other conditions that were considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University People's Hospital: collaborator
• Peking University Third Hospital: collaborator
• Beijing Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator

Study Sites (1)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (36)

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MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hopital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 10, 2012
• Study Start: November 21, 2011
• Primary Completion: May 25, 2015
• Study Completion: June 24, 2015
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)