Clinical trial NCT03629262: Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery
Official title: Impact of Dexmedetomidine Supplemented Intravenous Analgesia on Postoperative Delirium and Long-term Outcomes in Elderly After Orthopedic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Elderly
Orthopedic Surgery
Analgesia
Dexmedetomidine
Postoperative Delirium
Long-term Outcome
Keywords: Elderly
Orthopedic Surgery
Analgesia
Dexmedetomidine
Postoperative Delirium
Long-term Outcome
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
First posted: 2018-08-14
Enrollment: 712
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.

Detailed description: A growing number of elderly patients undergo orthopedic surgery each year. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. The investigators hypothesize that dexmedetomidine supplemented intravenous analgesia (in the form of patient-controlled analgesia) can also reduce delirium and improve long-term outcomes in elderly patients after orthopedic surgery.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years but \< 90 years;
* Scheduled to undergo total knee/hip replacement surgery, or spinal surgery;
* Planned to use patient-controlled intravenous analgesia (PCIA) after surgery.

Exclusion Criteria:

* Refuse to participate in this study;
* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
* Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
* Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
* Sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C);
* Severe renal dysfunction (requirement of renal replacement therapy before surgery);
* American Society of Anesthesiologists physical status \>IV, or estimated survival ≤24 h.

Primary outcomes:
measure: Incidence of delirium within the first 5 days after surgery
timeFrame: The first 5 days after surgery
Secondary outcomes:
measure: Daily prevalence of delirium during the first 5 days after surgery
timeFrame: The first 5 days after surgery
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of non-delirium complications with 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: All-cause 30-day mortality
timeFrame: Up to 30 days after surgery
measure: Quality of life of 30-day survivors
timeFrame: At 30 days after surgery
measure: Cognitive function of 30-day survivors
timeFrame: At 30 days after surgery
measure: Agitation or sedation level during postoperative days 1-5
timeFrame: The first 1-5 days after surgery
measure: Cumulative sufentanil consumption within 5 postoperative days
timeFrame: Up to 5 days after surgery
measure: Pain severity during postoperative days 1-5
timeFrame: The first 1-5 days after surgery
measure: Subjective sleep quality during postoperative days 1-5
timeFrame: The first 1-5 days after surgery
measure: Overall survival for up to 3 years after surgery
timeFrame: Up to 3 years after surgery
measure: Event-free survival for up to 3 years after surgery
timeFrame: Up to 3 years after surgery
measure: Quality of life in 1-，2- and 3-year survivors after surgery
timeFrame: At the end of the 1st, 2nd, and 3rd year after surgery
measure: Cognitive function in 1-，2- and 3-year survivors after surgery
timeFrame: At the end of the 1st, 2nd, and 3rd year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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