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NCT Number: NCT03629262

Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery

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.

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Key information

Conditions

Elderly Agnosia Analgesia Confusion Delirium Dexmedetomidine Emergence Delirium Long-term Outcome Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Orthopedic Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Delirium Signs and Symptoms

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Jishuitan Hospital, Beijing, Beijing Municipality, China

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About this study

A growing number of elderly patients undergo orthopedic surgery each year. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. The investigators hypothesize that dexmedetomidine supplemented intravenous analgesia (in the form of patient-controlled analgesia) can also reduce delirium and improve long-term outcomes in elderly patients after orthopedic surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

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.

Other names: Sufentanil analgesia

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.

Other names: Sufentanil analgesia

Primary outcomes

  1. Incidence of delirium within the first 5 days after surgery

    Time frame: The first 5 days after surgery

    Incidence of delirium within the first 5 days after surgery

Secondary outcomes

  1. Daily prevalence of delirium during the first 5 days after surgery

    Time frame: The first 5 days after surgery

    Daily prevalence of delirium during the first 5 days after surgery

  2. Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in hospital after surgery

  3. Incidence of non-delirium complications with 30 days after surgery

    Time frame: Up to 30 days after surgery

    Incidence of non-delirium complications with 30 days after surgery

  4. All-cause 30-day mortality

    Time frame: Up to 30 days after surgery

    All-cause 30-day mortality

  5. Quality of life of 30-day survivors

    Time frame: At 30 days after surgery

    Quality of life of 30-day survivors is assessed with World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function.

  6. Cognitive function of 30-day survivors

    Time frame: At 30 days after surgery

    Cognitive function of 30-day survivors is assessed with the 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 48, with higher score indicating better function.

  7. Agitation or sedation level during postoperative days 1-5

    Time frame: The first 1-5 days after surgery

    Agitation or sedation level is assessed twice daily 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).

  8. Cumulative sufentanil consumption within 5 postoperative days

    Time frame: Up to 5 days after surgery

    Cumulative sufentanil consumption within 5 postoperative days

  9. Pain severity during postoperative days 1-5

    Time frame: The first 1-5 days after surgery

    Pain severity is assessed with twice daily the Numeric Rating Scale (NRS), an 11 point scale where 0=no pain and 10=the worst possible pain.

  10. Subjective sleep quality during postoperative days 1-5

    Time frame: The first 1-5 days after surgery

    Subjective sleep quality is assessed once daily with the Numeric Rating Scale (NRS), an 11 point scale where 0=the best sleep and 10=the worst sleep.

  11. Overall survival for up to 3 years after surgery

    Time frame: Up to 3 years after surgery

    Time from surgery to all-cause death for up to 3 years after surgery.

  12. Event-free survival for up to 3 years after surgery

    Time frame: Up to 3 years after surgery

    Time from surgery to new-onset diseases or all-cause death, whichever comes first. New-onset disease indicates those that required hospital admission and/or interventional procedure.

  13. Quality of life in 1-，2- and 3-year survivors after surgery

    Time frame: At the end of the 1st, 2nd, and 3rd year after surgery

    Quality of life in 1-，2- and 3-year survivors is assessed with the WHOQOL-BREF, a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function.

  14. Cognitive function in 1-，2- and 3-year survivors after surgery

    Time frame: At the end of the 1st, 2nd, and 3rd year after surgery

    Cognitive function in 1-，2- and 3-year survivors is assessed with the 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 48, with higher score indicating better function.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Jishuitan Hospital

Registry information

Official study title

Impact of Dexmedetomidine Supplemented Intravenous Analgesia on Postoperative Delirium and Long-term Outcomes in Elderly After Orthopedic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Aug 14, 2018
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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