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

NCT03289325 | Completed

• 1 other identifier: 2016-1188
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Surgery; Dexmedetomidine; Long-term Outcome; Mortality; Quality of Life

Keywords

Cardiac surgery; Dexmedetomidine; Long-term outcome; Mortality; Quality of life

Outcome Measures

Primary Outcomes (1)

• Overall survival after surgery

  Overall survival after surgery

  Up to 6 years after surgery

Secondary Outcomes (4)

• Major adverse cardiovascular events-free survival after surgery

  Up to 6 years after surgery

• Hospital-free survival after surgery

  Up to 6 years after surgery

• Cognitive function in 6-year survivors after surgery

  At the 6th year after surgery

• Health related quality of life in 6-year survivors after surgery

  At the 6th year after surgery

Study Arms (2)

DEX group

EXPERIMENTAL

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.

Drug: dexmedetomidine hydrochloride for injection

CTRL group

PLACEBO COMPARATOR

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.

Drug: 0.9% sodium chloride for injection

Interventions

dexmedetomidine hydrochloride for injection DRUG

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.

Also known as: Aibeining (trade name)

DEX group

0.9% sodium chloride for injection DRUG

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.

Also known as: Normal saline

CTRL group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 60 years or older;
• Scheduled to undergo cardiac surgery (coronary artery bypass graft and/or valve replacement surgery);
• Provide written informed consents.

You may not qualify if:

• Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
• Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
• History of brain injury or neurosurgery;
• Preoperative sick sinus syndrome, severe bradycardia (HR \< 50 bpm), second-degree or above atrioventricular block without pacemaker;
• Severe hepatic dysfunction (Child-Pugh class C);
• Severe renal dysfunction (requirement of renal replacement therapy);
• Other conditions that are considered unsuitable for participation.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (24)

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  PMID: 40097932 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Injections; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: October 21, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: October 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)