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Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

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ClinicalTrials.gov Identifier: NCT03629483
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
Beijing Jishuitan Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Elderly Knee Arthroplasty Nerve Block Dexmedetomidine Postoperative Delirium Long-term Outcome Drug: Dexmedetomidine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Dexmedetomidine group
For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours (equivalent to dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
Drug: Dexmedetomidine
Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h (equivalent to a dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
Other Name: Continuous femoral nerve block with ropivacaine

Placebo Comparator: Control group
For patients in the control group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and placebo (normal saline). The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours.
Drug: Placebo
Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250 ml and placebo. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h.
Other Name: Continuous femoral nerve block with ropivacaine




Primary Outcome Measures :
  1. Incidence of delirium during the first 3 days after surgery [ Time Frame: The first 3 days after surgery ]
    Incidence of delirium during the first 3 days after surgery


Secondary Outcome Measures :
  1. Daily prevalence of delirium during postoperative days 1-3 [ Time Frame: The first 3 days after surgery ]
    Daily prevalence of delirium during postoperative days 1-3

  2. Length of stay in hospital after surgery [ Time Frame: Up to 30 days after surgery ]
    Length of stay in hospital after surgery

  3. Incidence of non-delirium complications within 30 days after surgery [ Time Frame: Up to 30 days after surgery ]
    Incidence of non-delirium complications within 30 days after surgery

  4. All-cause 30-day mortality [ Time Frame: At 30 days after surgery ]
    All-cause 30-day mortality

  5. Quality of life at 30 days after surgery [ Time Frame: At 30 days after surgery ]
    Quality of life at 30 days after surgery is assessed with the 12-items Short Form Health Survey (SF-12), a 12-item questionnaire that provides assessments of physical and mental health-related quality of life. The score ranges from 12 to 48, with higher score indicating better function.

  6. Cognitive function at 30 days after surgery [ Time Frame: At 30 days after surgery ]
    Cognitive function at 30 days after surgery is assessed with modified Telephone Interview for Cognitive Status (TICS-m), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function.

  7. Overall survival within 3 years after surgery [ Time Frame: Up to 3 years after surgery ]
    Overall survival within 3 years after surgery

  8. Survival rates at the end of the 1st,2nd, and 3rd years after surgery [ Time Frame: At the end of the 1st, 2nd, and 3rd years after surgery ]
    Survival rates at the end of the 1st,2nd, and 3rd years after surgery

  9. Incidence of new-onset diseases within 3 years after surgery [ Time Frame: Up to 3 years after surgery ]
    Incidence of new-onset diseases within 3 years after surgery

  10. Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12 [ Time Frame: At the end of the 1st, 2nd, and 3rd years after surgery ]
    Quality of life at the end of the 1st, 2nd, and 3rd years after surgery is assessed with the 12-items Short Form Health Survey (SF-12), a 12-item questionnaire that provides assessments of physical and mental health-related quality of life. The score ranges from 12 to 48, with higher score indicating better function.

  11. Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery [ Time Frame: At the end of the 1st, 2nd, and 3rd years after surgery ]
    Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery is assessed with modified Telephone Interview for Cognitive Status (TICS-m), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function.


Other Outcome Measures:
  1. Sedation level during postoperative days 1-3 [ Time Frame: The first 3 days after surgery ]
    Sedation level during postoperative days 1-3 is assessed with the Richmond Agitation-Sedation Scale (RASS), of which the range is as follows: +4 (combative), +3 (very agitated), +2 (agitated), +1 (restless), 0 (alert and clam), -1 (drowsy), -2 (light sedation), -3 (moderate sedation), -4 (deep sedation), and -5 (unarousable).

  2. Pain severity during postoperative days 1-3: NRS [ Time Frame: The first 3 days after surgery ]
    Pain severity during postoperative days 1-3 is assessed with the Numeric Rating Scale (NRS), an 11-point pain scale where 0=no pain and 10=the most severe pain.

  3. Sleep quality during postoperative days 1-3 [ Time Frame: The first 3 days after surgery ]
    Sleep quality during postoperative days 1-3 is assessed with the Verran and Snyder-Halpern (VSH) Sleep Scale, an 8-item questionnaire that evaluate multiple aspects of sleep during the previous night. Each item is scored in a range from 0 (very bad) to 10 (very good), and the total VSH score is determined by the summation of these scores (range 0-80). A higher total VSH score indicates a better quality of sleep.



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629483


Contacts
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Contact: Dong-Xin Wang, MD, PhD 8610 83572784 wangdongxin@hotmail.com
Contact: Hong Hong, MD 8610 83572460 honghong920066@sina.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    8610 83572784    wangdongxin@hotmail.com   
Contact: Hong Hong, MD    83572784    honghong920066@sina.com   
Beijing Jishuitan Hospital Recruiting
Beijing, Beijing, China, 100035
Contact: Geng Wang, MD    861058516908    w_geng@163.com   
Contact: Xiao-Lin Wang, MD    861058518158    wxl2727@126.com   
Sponsors and Collaborators
Peking University First Hospital
Beijing Jishuitan Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications:

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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03629483    
Other Study ID Numbers: DEX 20180516
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Elderly
Knee Arthroplasty
Nerve Block
Dexmedetomidine
Postoperative Delirium
Long-term Outcome
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics