Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery

Peking University First Hospital712 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

712

Conditions

Elderly Orthopedic Surgery Analgesia Dexmedetomidine Postoperative Delirium Long-term Outcome

Interventions

DexmedetomidineDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Incidence of delirium within the first 5 days after surgery

Time frame: The first 5 days after surgery

Secondary Outcomes

Daily prevalence of delirium during the first 5 days after surgery

Time frame: The first 5 days after surgery

Length of stay in hospital after surgery

Time frame: Up to 30 days after surgery

Incidence of non-delirium complications with 30 days after surgery

Time frame: Up to 30 days after surgery

All-cause 30-day mortality

Time frame: Up to 30 days after surgery

Quality of life of 30-day survivors

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.

Time frame: At 30 days after surgery

Cognitive function of 30-day survivors

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.

Data from ClinicalTrials.gov

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