Elderly Clinical Trial
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
Verified date | April 2022 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 736 |
Est. completion date | December 2024 |
Est. primary completion date | December 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Jishuitan Hospital | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | Beijing Jishuitan Hospital |
China,
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Wang XL, Wang J, Mu DL, Wang DX. [Dexmedetomidine combined with ropivacaine for continuous femoral nerve block improved postoperative sleep quality in elderly patients after total knee arthroplasty]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):728-732. doi: 10.3760/cma.j.issn.0376-2491.2018.10.003. Chinese. — View Citation
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sedation level during postoperative days 1-3 | 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). | The first 3 days after surgery | |
Other | Pain severity during postoperative days 1-3: NRS | 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. | The first 3 days after surgery | |
Other | Sleep quality during postoperative days 1-3 | 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. | The first 3 days after surgery | |
Primary | Incidence of delirium during the first 3 days after surgery | Incidence of delirium during the first 3 days after surgery | The first 3 days after surgery | |
Secondary | Daily prevalence of delirium during postoperative days 1-3 | Daily prevalence of delirium during postoperative days 1-3 | The first 3 days after surgery | |
Secondary | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery | |
Secondary | Incidence of non-delirium complications within 30 days after surgery | Incidence of non-delirium complications within 30 days after surgery | Up to 30 days after surgery | |
Secondary | All-cause 30-day mortality | All-cause 30-day mortality | At 30 days after surgery | |
Secondary | Quality of life 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. | At 30 days after surgery | |
Secondary | Cognitive function 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. | At 30 days after surgery | |
Secondary | Overall survival within 3 years after surgery | Overall survival within 3 years after surgery | Up to 3 years after surgery | |
Secondary | Survival rates 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 | At the end of the 1st, 2nd, and 3rd years after surgery | |
Secondary | Incidence of new-onset diseases within 3 years after surgery | Incidence of new-onset diseases within 3 years after surgery | Up to 3 years after surgery | |
Secondary | Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12 | 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. | At the end of the 1st, 2nd, and 3rd years after surgery | |
Secondary | Cognitive function 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. | At the end of the 1st, 2nd, and 3rd years after surgery |
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