Nocturnal Low-dose Dexmedetomidine Infusion and Perioperative Sleep Quality

NCT05246007 | Withdrawn DMC

• 1 other identifier: 2021-639
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic properties. It exerts sedative effects via activating the endogenous sleep pathways and produces a state like non-rapid eye movement sleep, which is different from opioid- and benzodiazepine-induced sedation. Night-time infusion of low-dose dexmedetomidine may improve sleep quality. However, evidence in this aspect is limited.

Conditions

Old Age; Knee Replacement Surgery; Hip Replacement Surgery; Dexmedetomidine; Sleep Quality

Keywords

Old Age; Knee replacement surgery; Hip replacement surgery; Dexmedetomidine; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Subjective sleep quality (overall RCSQ score) during the night of surgery.

  Subjective sleep quality will be assessed in the morning (between 8:00 am to 10:00 am) using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure that evaluated perception of nighttime sleep in five items, including sleep depth, sleep latency, number of awakenings, returning to sleep, and overall sleep quality. Each item was assessed with a 100-millimeter visual analog scale (VAS; score ranges from 0 to 100, with higher scores representing better sleep). The mean score of the five items represents the overall RCSQ score. The RCSQ also included a sixth item, not included in the overall score, that evaluated perceived nighttime noise (score ranges from 0 to 100, where 0="very noisy" and 100="very quiet").

  During the night of surgery.

Secondary Outcomes (17)

• Subjective sleep quality (overall RCSQ score) during the perioperative period.

  From the night before surgery until the fifth night after surgery.

• Total sleep time per night during the perioperative period.

  From the night before surgery until the fifth night after surgery.

• Sleep efficiency per night during the perioperative period.

  From the night before surgery until the fifth night after surgery.

• Sleep onset latency per night during the perioperative period.

  From the night before surgery until the fifth night after surgery.

• Wake after sleep onset per night during the perioperative period.

  From the night before surgery until the fifth night after surgery.

Other Outcomes (1)

• Cerebrospinal fluid proteomics examination (selected patients).

  During anesthesia.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Placebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).

Also known as: Dexmedetomidine for infusion

Dexmedetomidine group

Normal Saline DRUG

Placebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).

Also known as: Normal Saline for infusion

Placebo group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years and \<90 years;
• Scheduled to undergo unilateral knee or hip arthroplasty under spinal or combined spinal-epidural anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Hospital: collaborator

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (12)

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  PMID: 19654581 BACKGROUND

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  PMID: 24136970 BACKGROUND

• Onen SH, Onen F, Courpron P, Dubray C. How pain and analgesics disturb sleep. Clin J Pain. 2005 Sep-Oct;21(5):422-31. doi: 10.1097/01.ajp.0000129757.31856.f7.

  PMID: 16093748 BACKGROUND

• Lintzeris N, Moodley R, Campbell G, Larance B, Bruno R, Nielsen S, Degenhardt L. Sleep Quality Among People Living With Chronic Noncancer Pain: Findings From the Pain and Opioids IN Treatment (POINT) Cohort. Clin J Pain. 2016 May;32(5):380-7. doi: 10.1097/AJP.0000000000000282.

  PMID: 26218004 BACKGROUND

• Er MS, Altinel EC, Altinel L, Erten RA, Eroglu M. An assessment of sleep quality in patients undergoing total knee arthroplasty before and after surgery. Acta Orthop Traumatol Turc. 2014;48(1):50-4. doi: 10.3944/AOTT.2014.3163.

  PMID: 24643100 BACKGROUND

• Sasaki E, Tsuda E, Yamamoto Y, Maeda S, Inoue R, Chiba D, Okubo N, Takahashi I, Nakaji S, Ishibashi Y. Nocturnal knee pain increases with the severity of knee osteoarthritis, disturbing patient sleep quality. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1027-32. doi: 10.1002/acr.22258.

  PMID: 24470323 BACKGROUND

• Fatah RMN, Abdulrahman BB. A sleep disturbance after total knee arthroplasty. J Family Med Prim Care. 2020 Jan 28;9(1):119-124. doi: 10.4103/jfmpc.jfmpc_595_19. eCollection 2020 Jan.

  PMID: 32110576 BACKGROUND

• Alexopoulou C, Kondili E, Diamantaki E, Psarologakis C, Kokkini S, Bolaki M, Georgopoulos D. Effects of dexmedetomidine on sleep quality in critically ill patients: a pilot study. Anesthesiology. 2014 Oct;121(4):801-7. doi: 10.1097/ALN.0000000000000361.

  PMID: 24988068 BACKGROUND

• Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.

  PMID: 27571256 BACKGROUND

• Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.

  PMID: 27542303 BACKGROUND

• Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.

  PMID: 29742525 BACKGROUND

• Li HJ, Li CJ, Wei XN, Hu J, Mu DL, Wang DX. Dexmedetomidine in combination with morphine improves postoperative analgesia and sleep quality in elderly patients after open abdominal surgery: A pilot randomized control trial. PLoS One. 2018 Aug 14;13(8):e0202008. doi: 10.1371/journal.pone.0202008. eCollection 2018.

  PMID: 30106963 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)