Status:

COMPLETED

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

Lead Sponsor:

Peking University First Hospital

Conditions:

Overall Survival

Eligibility:

All Genders

60+ years

Phase:

PHASE4

Brief Summary

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 ...

Detailed 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 ana...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

October 7 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2021

Estimated Enrollment :

619 Patients enrolled

Trial Details

Trial ID

NCT04111926

Start Date

October 7 2019

End Date

April 1 2021

Last Update

April 20 2022

Active Locations (1)

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Peking University First Hospital

Beijing, Beijing Municipality, China, 100034