Dexmedetomidine and Long-term Outcomes in Elderly Patients After Cardiac Surgery

October 28, 2023 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Perioperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Cardiac Surgery: 6-year Follow-up of a Randomized Controlled Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

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

    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100037
        • Beijing Fuwai 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

Description

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.

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: DEX group
The active drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery.

Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml).

Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 ug/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 ug/kg/h) until the end of surgery.

After surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation.

Other Names:
  • Aibeining (trade name)
Placebo Comparator: CTRL group
The placebo drug (normal saline, or 0.9% sodium chloride for injection) will be administered in the same rate and volume for a same duration as that in the DEX group.

Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared.

Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery.

After surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation.

Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after surgery
Time Frame: Up to 6 years after surgery
Overall survival after surgery
Up to 6 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events-free survival after surgery
Time Frame: Up to 6 years after surgery
Major adverse cardiovascular events include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and myocardial revascularization.
Up to 6 years after surgery
Hospital-free survival after surgery
Time Frame: Up to 6 years after surgery
Event indicates any medical condition that lead to hospitalization after surgery.
Up to 6 years after surgery
Cognitive function in 6-year survivors after surgery
Time Frame: At the 6th year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M; scores range from 0 to 50, with higher score indicating better cognitive function).
At the 6th year after surgery
Health related quality of life in 6-year survivors after surgery
Time Frame: At the 6th year after surgery
Health related quality of life is assessed with the short-form 36-item health survey questionnaire (SF-36). The SF-36 scale measures eight aspects of health status, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. It also measures changes of subjective healthy status during the last year (reported health transition). The scores of the above 9 items are calculated separately with scores range from 0 to 100, with higher score indicating better quality.
At the 6th year after surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, 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)

December 5, 2016

Primary Completion (Actual)

May 3, 2022

Study Completion (Actual)

May 3, 2022

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 28, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

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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