Clinical trial NCT03629483: Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block
Official title: Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Elderly
Knee Arthroplasty
Nerve Block
Dexmedetomidine
Postoperative Delirium
Long-term Outcome
Keywords: Elderly
Knee Arthroplasty
Nerve Block
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: 736
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
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. Continuous femoral nerve block is frequently used for postoperative analgesia after total knee arthoplasty. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Detailed description: A growing number of elderly patients undergo total knee arthroplasty. 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. Dexmedetomidine has been shown to prolong the duration of nerve block without neurotoxicity and improve postoperative sleep quality. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Elderly patients (≥ 65 years but \< 90 years);
* Scheduled to undergo single total knee arthroplasty;
* Planned to receive continuous femoral nerve block for postoperative analgesia.

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 hemorrhagic disease or coagulopathy (platelet count, prothrombin time and/or activated partial thrombin time below the lower limit of normal);
* Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score ≥3);
* Preoperative 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);
* ASA classification ≥ IV or unlikely to survive for more than 24 hours after surgery.

Primary outcomes:
measure: Incidence of delirium during the first 3 days after surgery
timeFrame: The first 3 days after surgery
Secondary outcomes:
measure: Daily prevalence of delirium during postoperative days 1-3
timeFrame: The first 3 days after surgery
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of non-delirium complications within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: All-cause 30-day mortality
timeFrame: At 30 days after surgery
measure: Quality of life at 30 days after surgery
timeFrame: At 30 days after surgery
measure: Cognitive function at 30 days after surgery
timeFrame: At 30 days after surgery
measure: Overall survival within 3 years after surgery
timeFrame: Up to 3 years after surgery
measure: Survival rates at the end of the 1st，2nd, and 3rd years after surgery
timeFrame: At the end of the 1st, 2nd, and 3rd years after surgery
measure: Incidence of new-onset diseases within 3 years after surgery
timeFrame: Up to 3 years after surgery
measure: Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12
timeFrame: At the end of the 1st, 2nd, and 3rd years after surgery
measure: Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery
timeFrame: At the end of the 1st, 2nd, and 3rd years after surgery
Other outcomes:
measure: Sedation level during postoperative days 1-3
timeFrame: The first 3 days after surgery
measure: Pain severity during postoperative days 1-3: NRS
timeFrame: The first 3 days after surgery
measure: Sleep quality during postoperative days 1-3
timeFrame: The first 3 days after surgery
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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