Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery

NCT03629262 | Completed Phase 4 DMC

• 2 other identifiers: 2018-131ChiCTR1800017182
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 2

Brief Summary

Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.

Conditions

Elderly; Orthopedic Surgery; Analgesia; Dexmedetomidine; Postoperative Delirium; Long-term Outcome

Keywords

Elderly; Orthopedic Surgery; Analgesia; Dexmedetomidine; Postoperative Delirium; Long-term Outcome

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within the first 5 days after surgery

  Incidence of delirium within the first 5 days after surgery

  The first 5 days after surgery

Secondary Outcomes (14)

• Daily prevalence of delirium during the first 5 days after surgery

  The first 5 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of non-delirium complications with 30 days after surgery

  Up to 30 days after surgery

• All-cause 30-day mortality

  Up to 30 days after surgery

• Quality of life of 30-day survivors

  At 30 days after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of patient-controlled intravenous analgesia. The formula contains a mixture of sufentanil (1.25 ug/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a patient-controlled bolus of 2 ml each time and a lockout interval of 8 minutes.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

For patients in the control group, postoperative analgesia is provided in the form of patient-controlled intravenous analgesia. The formula contains a mixture of placebo and sufentanil (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a patient-controlled bolus of 2 ml each time and a lockout interval of 8 minutes.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and sufentanil (1.25 ug/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.

Also known as: Sufentanil analgesia

Dexmedetomidine group

Placebo DRUG

Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of placebo and sufentanil (1.25 ug/m), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.

Also known as: Sufentanil analgesia

Control group

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years but \< 90 years;
• Scheduled to undergo total knee/hip replacement surgery, or spinal surgery;
• Planned to use patient-controlled intravenous analgesia (PCIA) after surgery.

You may not qualify if:

• 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 obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
• 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);
• American Society of Anesthesiologists physical status \>IV, or estimated survival ≤24 h.

Sponsors & Collaborators

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

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 102208, China

Location

Related Publications (24)

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  PMID: 34517840 DERIVED

MeSH Terms

Conditions

Agnosia; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: October 28, 2018
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2022
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)