Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery

NCT05537155 | Withdrawn DMC

• 1 other identifier: 2022-220
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to test the hypothesis that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

Conditions

Older Patients; Orthopedic Surgery; Postoperative Delirium; Acupuncture; Treatment

Keywords

Older patients; Orthopedic surgery; Postoperative delirium; Buccal acupuncture; Treatment effects

Outcome Measures

Primary Outcomes (1)

• Number of delirium-free days within 5 days

  Delirium will be assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the 3D-Confusion Assessment Method (3D-CAM) for non-intubated patients or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for intubated patients.

  Up to 5 days after enrollment

Secondary Outcomes (5)

• Delirium severity within 5 days

  Up to 5 days after enrollment

• Time to first delirium resolution

  Up to 5 days after enrollment

• Delirium subtype

  Up to 5 days after enrollment

• Length of hospital stay after surgery

  Up to 30 days after surgery

• Quality of life at 30 days after surgery

  At 30 days after surgery

Other Outcomes (4)

• Pain intensity

  Up to 5 days after enrollment

• Subjective sleep quality

  Up to 5 days after enrollment

• Non-delirium complications

  Up to 30 days after surgery

Study Arms (2)

Buccal acupuncture

EXPERIMENTAL

Buccal acupuncture will be performed in addition to routine care.

Procedure: Buccal acupuncture in addition to routine care

Routine care

ACTIVE COMPARATOR

Routine care will be provided.

Other: Routine care

Interventions

Buccal acupuncture in addition to routine care PROCEDURE

Acupuncture will be performed at a depth of 10 mm, with the needle retaining for 20 min, in addition to routine care. Bilateral acupoints include "Tou", "Shangjing", "Jing", "Bei", and "Sanjiao". Unilateral acupoints is related to surgical sites and include "Kuan" in hip joint replacement surgery and "Xi" in knee joint replacement surgery. Patients with agitation will be treated first until agitation is controlled before acupuncture is performed.

Buccal acupuncture

Routine care OTHER

Routing care includes the following: (1) remove the precipitating cause and treat the primary disease; and (2) supportive care, including reorientation and cognitive stimulation, sleep enhancement, early mobility and exercise, vision and hearing optimization, family engagement and empowerment, and early oral intake and nutrition.

Routine care

Eligibility Criteria

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

You may qualify if:

• Aged ≥65 years, but \<90 years.
• After knee or hip replacement surgery.
• Diagnosed with delirium in the morning of enrollment.

You may not qualify if:

• Refuse to participate in the study.
• Presence of any contraindications to acupuncture, such as puncture site infections or platelet count ≤20×10\^9/L.
• Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
• Inability to communicate due to coma, profound dementia, or language barrier, or inability to cooperate with treatment due to agitation.
• American Society of Anesthesiologists physical status grade ≥V, or estimated survival ≤24 h.

Sponsors & Collaborators

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

Related Publications (21)

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• Berian JR, Zhou L, Russell MM, Hornor MA, Cohen ME, Finlayson E, Ko CY, Rosenthal RA, Robinson TN. Postoperative Delirium as a Target for Surgical Quality Improvement. Ann Surg. 2018 Jul;268(1):93-99. doi: 10.1097/SLA.0000000000002436.

  PMID: 28742701 BACKGROUND

• Rong X, Ding ZC, Yu HD, Yao SY, Zhou ZK. Risk factors of postoperative delirium in the knee and hip replacement patients: a systematic review and meta-analysis. J Orthop Surg Res. 2021 Jan 22;16(1):76. doi: 10.1186/s13018-020-02127-1.

  PMID: 33482875 BACKGROUND

• Zhou Q, Zhou X, Zhang Y, Hou M, Tian X, Yang H, He F, Chen X, Liu T. Predictors of postoperative delirium in elderly patients following total hip and knee arthroplasty: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2021 Nov 12;22(1):945. doi: 10.1186/s12891-021-04825-1.

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MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: October 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07