Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery

Peking University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Placebo; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03629262

2018-131

ChiCTR1800017182 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 712 patients

Sex: All

Ages: 65 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

712 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo