Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery

NCT03624595 | Completed DMC

• 1 other identifier: 2018-181
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 2

Brief Summary

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.

Conditions

Cardiac Surgery; Dexmedetomidine; Delirium; Survival; Cardiopulmonary Bypass

Keywords

Cardiac Surgery; Cardiopulmonary Bypass; Dexmedetomidine; Delirium; Survival

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within the first 5 days after surgery

  Delirium is assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the Confusion Assessment Method (CAM, for patients without mechanical ventilation) or CAM for the intensive care unit (CAM-ICU, for patients with mechanical ventilation) during postoperative days 1-5.

  During the first 5 days after surgery

Secondary Outcomes (7)

• Duration of mechanical ventilation after surgery

  Up to 30 days after surgery

• Length of stay in ICU after surgery

  Up to 30 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of Major Adverse Cardiovascular Events (MACEs) within 30 days after surgery

  Up to 30 days after surgery

• Incidence of other complications

  Up to 30 days after surgery

Other Outcomes (8)

• Alterations of sleep architecture (a subset of patients)

  During the night of surgery

• The Numeric Rating Scale (NRS) pain score within 5 days after surgery.

  At 2, 6, 24, 48, 72, 96, and 120 hours (i.e., the 5th day) after surgery.

• Subjective sleep quality within 5 days after surgery

  During the first 5 days after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Placebo (normal saline) infusion is administered from 16:00 to 08:00 in the same speed for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery in the intensive care unit; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.

Also known as: Low-dose dexmedetomidine infusion

Dexmedetomidine group

Placebo DRUG

Placebo (normal saline) infusion is administered in the same rate for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.

Also known as: Normal saline infusion

Placebo group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years but \<90 years;
• Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia;
• Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded.
• Refuse to participate in the study;
• Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
• Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender \[STOP-Bang\] questionnaires ≥3);
• Inability to communicate during the preoperative period because of coma, profound dementia or language barrier;
• Preoperative sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree atrioventricular block or above without pacemaker;
• Severe hepatic dysfunction (Child-Pugh class C);
• Severe renal dysfunction (requirement of renal replacement therapy) before surgery;
• Presence of delirium (diagnosed by the Confusion Assessment Method \[CAM\]/CAM for the Intensive Care Unit \[CAM-ICU\]);
• Current treatment with dexmedetomidine or clonidine.

Sponsors & Collaborators

• Dong-Xin Wang: lead
• Fu Wai Hospital, Beijing, China: collaborator

Study Sites (2)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Fuwai Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (35)

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MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 10, 2018
• Study Start: April 16, 2019
• Primary Completion: July 3, 2021
• Study Completion: May 18, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)