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

April 18, 2022 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

619

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University first hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Drug: Dexmedetomidine
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 Comparator: Control group
Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
Drug: Placebo
Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival within 3 years after surgery
Time Frame: Up to 3 years after surgery.
Overall survival within 3 years after surgery
Up to 3 years after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival within 3 years after surgery.
Time Frame: Up to 3 years after surgery.
Recurrence-free survival within 3 years after surgery.
Up to 3 years after surgery.
Cancer-specific survival within 3 years after surgery.
Time Frame: Up to 3 years after surgery.
Cancer-specific survival within 3 years after surgery.
Up to 3 years after surgery.
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.
Up to 3 years after surgery.
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.
At 3 years after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0927

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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