Clinical trial NCT03289325: Dexmedetomidine and Long-term Outcomes in Elderly Patients After Cardiac Surgery
Official title: Impact of Perioperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Cardiac Surgery: 6-year Follow-up of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Dexmedetomidine
Long-term Outcome
Mortality
Quality of Life
Keywords: Cardiac surgery
Dexmedetomidine
Long-term outcome
Mortality
Quality of life
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2017-09-20
Enrollment: 285
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A retrospective study showed that intraoperative dexmedetomidine administration was associated with decreased risk of 1-year mortality after cardiac surgery. In a previous randomized controlled trial, 285 elderly patients undergoing cardiac surgery were randomized to receive either perioperative dexmedetomidine or placebo (normal saline) administration. The purpose of this 6-year follow-up study is to investigate whether perioperative dexmedetomidine can improve long-term outcomes in those recruited elderly patients after cardiac surgery.

Detailed description: Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist that provides anti-anxiety, sedation, and modest analgesic effects. In a retrospective cohort study of patients undergoing cardiac surgery, perioperative dexmedetomidine administration was associated with decreased risk of 1-year mortality. Theoretically, perioperative dexmedetomidine may exert the following favorable for cardiac surgery patients: (1) reduces perioperative opioid consumption and thereby mitigates opioid-induced immunosuppression, (2) dampens hyper-inflammatory response induced by surgery, and (3) improves postoperative sleep quality. However, prospective studies investigating the long-term effects of perioperative dexmedetomidine in cardiac surgery patients are still lacking.

In a previous randomized controlled trial, 285 patients of 60 years or older who were scheduled to undergo coronary artery bypass graft surgery and/or valve replacement surgery were randomized to receive either perioperative dexmedetomidine administration (0.6 microgram/kg in 10 minutes before anesthesia induction, followed by a continuous infusion at a rate of 0.4 microgram/kg/h until the end of surgery, then a continuous infusion at a rate of 0.1 microgram/kg/h until the end of mechanical ventilation) or placebo (normal saline, administered in the same rate or volume for the same duration as in the dexmedetomidine group). The results showed that perioperative dexmedetomidine reduced the incidence of pulmonary complications and shortened the duration of mechanical ventilation after surgery.

The purpose of this 6-year follow-up study is to investigate the effects of perioperative dexmedetomidine on the long-term outcomes in elderly patients after cardiac surgery.

Eligibility criteria: Inclusion Criteria:

1. Age of 60 years or older;
2. Scheduled to undergo cardiac surgery (coronary artery bypass graft and/or valve replacement surgery);
3. Provide written informed consents.

Exclusion Criteria: Patients who meet any of the following criteria will be excluded.

1. Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
2. Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
3. History of brain injury or neurosurgery;
4. Preoperative sick sinus syndrome, severe bradycardia (HR \< 50 bpm), second-degree or above atrioventricular block without pacemaker;
5. Severe hepatic dysfunction (Child-Pugh class C);
6. Severe renal dysfunction (requirement of renal replacement therapy);
7. Other conditions that are considered unsuitable for participation.

Primary outcomes:
measure: Overall survival after surgery
timeFrame: Up to 6 years after surgery
Secondary outcomes:
measure: Major adverse cardiovascular events-free survival after surgery
timeFrame: Up to 6 years after surgery
measure: Hospital-free survival after surgery
timeFrame: Up to 6 years after surgery
measure: Cognitive function in 6-year survivors after surgery
timeFrame: At the 6th year after surgery
measure: Health related quality of life in 6-year survivors after surgery
timeFrame: At the 6th year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Fuwai Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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