Intraoperative Dexmedetomidine and Long-term Outcomes in Elderly After Major Surgery

Peking University

Status and phase: Completed; Phase 4

Conditions: Overall Survival

Treatments: Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04111926

2019-0927

Details and patient eligibility

About

This is a 3-year follow-up of patients enrolled in a previous randomized controlled trial which showed that intraoperative dexmedetomidine reduced delirium in elderly patients after major non-cardiac surgery. The purpose of this study is to clarify the effects of intraoperative dexmedetomidine on long-term outcomes of these patients.

Full description

Dexmedetomidine is a highly selective α-2-receptor agonist with sedative, analgesic and anxiolytic effects. When used as an supplement during general anaesthesia, it reduces the consumption of the anaesthetics and relieves surgery-related stress response and inflammation. In a recent randomized ontrolled trial of the applicants, 620 elderly patients who underwent major non-cardiac surgery were randomized to receive dexmedetomidine or normal saline during general anesthesia. The results showed that use of dexmedetomidine reduced delirium (5.5% [17/309] with dexmedetomidine vs. 10.2% [32/310] with placebo, P=0.026) and 30-day non-delirium complications (9.4% [60/309] with dexmedetomidine vs. 26.1% [81/310] with placebo, P=0.047) after surgery.

The effects of intraoperative dexmedetomidine on long-term outcomes after surgery remains unclear. In another study of the applicants, use of low-dose dexemeditomidine in ICU patients after surgery increased survival up to 2 years and improve quality of life in 3-year survivors. On the contrary, it was reported in a retrospective study that intraoperative use of dexmedetomidine was associated with shortened overall survival in patients after lung cancer surgery. Therefore, it is urgent to clarify the impact of intraoperative dexemeditomidine on long-term outcomes of patients undergoing major surgery, especially those undergoing cancer surgery.

This study is a 3-year follow-up of patients who were enrolled in a randomzied controlled trial of the applicants in order to clarify the effects of intraoperative dexmedetomidine on long-term outcomes after surgery.

Enrollment: 619 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elderly patients (age ≥60 years);
• Scheduled to undergo elective major non-cardiac surgery with expected duration ≥2 hours under general anaesthesia.

Exclusion criteria

• Do not provide written informed consent;
• Previous history of schizophrenia, epilepsy or Parkinson's disease;
• Visual, hearing, language or other barriers which impede communication and preoperative delirium assessment;
• History of traumatic brain injury;
• Severe bradycardia (heart rate <40 beats per minutes), sick sinus syndrome, or atrioventricular block of degree 2 or above without pacemaker;
• Severe hepatic dysfunction (Child-Pugh grade C);
• Renal failure (requirement of renal replacement therapy);
• Neurosurgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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619 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery.

Treatment:

Drug: Dexmedetomidine

Control group

Placebo Comparator group

Description:

Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.

Treatment:

Drug: Placebo