Skip to main content
OpenTrials
Completed

NCT Number: NCT04111926

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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.

Other names: Dexmedetomidine Hydrochloride

Placebo

Drug

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

Other names: Normal saline

Primary outcomes

  1. Overall survival within 3 years after surgery

    Time frame: Up to 3 years after surgery.

    Overall survival within 3 years after surgery

Secondary outcomes

  1. Recurrence-free survival within 3 years after surgery.

    Time frame: Up to 3 years after surgery.

    Recurrence-free survival within 3 years after surgery.

  2. Cancer-specific survival within 3 years after surgery.

    Time frame: Up to 3 years after surgery.

    Cancer-specific survival within 3 years after surgery.

  3. Rate of new-onset disease or hospital readmission within 3 years after surgery.

    Time frame: Up to 3 years after surgery.

    Rate of new-onset disease or hospital readmission within 3 years after surgery.

  4. Quality of life in 3-year survivors.

    Time frame: At 3 years after surgery.

    Quality of life is assessed with the World Health Organization Quality of Life-Brief Version. It assesses the quality of life at 4 domains, i.e., physical, psychological, social relationships, and environment. The score of each domain ranges from 0 to 100, with higher score indicating better quality of life.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Impact of Intraoperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Major Non-cardiac Surgery: 3-year Follow-up of a Randomised Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2019
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.