Low-dose Dexmedetomidine in Mechanically Ventilated ICU Patients

NCT03172897 | Suspended Phase 4 DMC

• 1 other identifier: 2017[1319]
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

For patients undergoing mechanical ventilation, light sedation is better than deep sedation for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of mechanical ventilation, and decreased mortality. In a recent study of the investigators, low-dose dexmedetomidine without sedative effects (0.1 ug/kg/h) improved sleep quality and reduced the incidence of delirium in elderly patients admitted to the ICU after surgery. The investigators hypothesize that, for ICU patients with prolonged mechanical ventilation, low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in decreasing delirium. The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can reduce the incidence of delirium in ICU patients with prolonged duration of mechanical ventilation (\>= 24 hours).

Conditions

Adult Disease; Intensive Care Unit Syndrome; Mechanical Ventilation Complication; Delirium; Dexmedetomidine

Keywords

Adult; Intensive care unit; Mechanical ventilation; Delirium; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within the first 7 days after enrollment

  Assessment twice daily (in the morning from 0600 h to 1000 h and in the evening from 1800 h to 2000 h) with the Confusion Assessment Method for the ICU (CAM-ICU).

  From enrollment until 7 days.

Secondary Outcomes (7)

• Duration of mechanical ventilation

  From enrollment until extubation or 30 days.

• Length of stay in the ICU

  From enrollment until ICU discharge or 30 days.

• Length of stay in the hospital

  From enrollment until hospital discharge or 30 days.

• Occurrence of non-delirium complications

  From enrollment until 30 days.

• All-cause 30-day mortality

  On the 30th day after enrollment.

Other Outcomes (2)

• Pain intensity

  From enrollment until 7 days.

• Subjective sleep quality

  From enrollment until 7 days.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine is infused at a rate of 0.1 ug/kg/h for a maximum of 3 days.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Placebo (normal saline) is infused at a same rate as in the dexmedetomidine group for a maximum of 3 days.

Drug: Placebo (normal saline)

Interventions

Dexmedetomidine DRUG

Dexmedetomidine is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h (0.1 μg/kg per h) from study recruitment in the ICU for no more than 72 hours.

Also known as: Dexmedetomidine hydrochloride

Dexmedetomidine group

Placebo (normal saline) DRUG

Placebo (normal saline) is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h from study recruitment in the ICU for no more than 72 hours.

Also known as: Normal saline

Placebo group

Eligibility Criteria

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

You may qualify if:

• aged 18 years or older;
• admitted to the ICU;
• with expected duration of mechanical ventilation of more than 24 hours.

You may not qualify if:

• refused to participate;
• aged less than 18 years;
• pregnant;
• preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
• inability to communicate in the preoperative period (coma, profound dementia, or language barrier);
• brain injury or neurosurgery;
• known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (\<50 beats per min \[bpm\]), or second degree or greater atrioventricular block without pacemaker;
• severe hepatic dysfunction (Child-Pugh class C);
• severe renal dysfunction (undergoing dialysis before surgery);
• less likely to survive for more than 24 hours.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (29)

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MeSH Terms

Conditions

Disease; Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic 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: phase 4
• 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: April 17, 2017
• First Posted: June 1, 2017
• Study Start: August 20, 2017
• Primary Completion: August 21, 2017
• Study Completion: December 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)