Nocturnal Low-dose Dexmedetomidine Infusion and Perioperative Sleep Quality
Launched by PEKING UNIVERSITY FIRST HOSPITAL · Feb 17, 2022
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a low-dose infusion of a medication called dexmedetomidine can improve sleep quality in older adults who are scheduled for knee or hip replacement surgery. Many older patients experience sleep problems, which can lead to complications after surgery, such as confusion or heart issues. The researchers believe that dexmedetomidine, which helps promote natural sleep patterns, might help these patients rest better during the night before their surgery.
To participate in this trial, you need to be between 65 and 89 years old and scheduled for a knee or hip replacement surgery. However, if you have certain health conditions, like sleep apnea or severe heart problems, or if you've recently taken sleep medications, you might not be eligible. If you join the study, you will receive the medication at night leading up to your surgery, and the researchers will monitor your sleep quality to see if it improves. This study is important because better sleep could lead to a smoother recovery after surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥65 years and \<90 years;
- • Scheduled to undergo unilateral knee or hip arthroplasty under spinal or combined spinal-epidural anesthesia.
- Exclusion Criteria:
- • Refuse to participate;
- • Hypnotic therapy for sleep disorders within 3 months;
- • Presence of contraindications to intrathecal anesthesia;
- • Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
- • Diagnosed as obstructive sleep apnea, or at high risk of moderate to severe obstructive sleep apnea according to the STOP-Bang questionnaire;
- • Inability to communicate in the preoperative period because of coma, profound dementia, or language barrier;
- • Sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), or atrioventricular block above grade II without pacemaker implanted;
- • Severe hepatic dysfunction (Childe Pugh class C); renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours;
- • Receiving treatment with dexmedetomidine or clonidine;
- • Allergy to dexmedetomidine.
About Peking University First Hospital
Peking University First Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields to conduct rigorous studies aimed at improving patient outcomes and contributing to global medical knowledge. With a multidisciplinary team of skilled researchers and clinicians, Peking University First Hospital is dedicated to the ethical conduct of clinical research, ensuring the highest standards of safety and efficacy in its trials. The institution plays a vital role in translating scientific discoveries into effective treatments, thereby enhancing the quality of care for patients both locally and worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Beijing, , China
Beijing, Beijing, China
Beijing, Beijing, China
Beijing, Beijing, China
Patients applied
Trial Officials
Dong-Xin Wang, MD, PhD
Principal Investigator
Peking University First Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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