Impacts of Low-Dose Dexmedetomidine on Sleep Quality in Mechanically Ventilated ICU Patients

NCT03335527 | Completed Phase 4 DMC

• 1 other identifier: 2017[13]
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disturbances frequently occur in intensive care unit (ICU) patients undergoing mechanical ventilation. In a previous study, sedative dose dexmedetomidine (median 0.6 microgram/kg/h) improved sleep quality in mechanically ventilated patients. However, for mechanically ventilated patients, 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, non-sedative low-dose dexmedetomidine (0.1 microgram/kg/h) improved sleep quality in non-mechanically ventilated elderly patients admitted to the ICU after surgery. The investigators hypothesize that, in mechanically ventilated patients who are admitted to the ICU after surgery, low-dose dexmedetomidine may also improve sleep quality.

Conditions

Aged; Postoperative Period; Intensive Care Units; Mechanical Ventilation Complication; Sleep Disorders; Dexmedetomidine

Keywords

Aged; Postoperative period; Intensive Care Unit; Mechanical ventilation; Sleep quality; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Sleep quality during the night of surgery.

  Sleep quality assessed with Richards-Campbell Sleep Questionnaire at 08:00 on the first day after surgery.

  Assessed at 08:00 on the first day after surgery.

Secondary Outcomes (14)

• Incidence of delirium within the first 7 days after surgery.

  Assessed twice daily during the first 7 days after surgery.

• Sleep quality within the first 7 days after surgery.

  Assessed once daily during the first 7 days after surgery.

• Total sleep time

  Monitored with polysomnograph during the night of surgery.

• Sleep efficiency

  Monitored with polysomnograph during the night of surgery.

• Fragmented sleep index

  Monitored with polysomnograph during the night of surgery.

Other Outcomes (3)

• Pain intensity.

  Assessed during the first 7 days after surgery.

• Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).

  Assessed within 24 hours after ICU admission.

• Percentage of time within the target of sedation during mechanical ventilation.

  During mechanical ventilation, for a maximum of 3 days.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine is infused at a rate of 0.1 ug/kg/h during mechanical ventilation, 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 during mechanical ventilation, 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 0.1-0.2 ug/kg/h (0.025-0.05 ml/kg/h) from study recruitment in the ICU during mechanical ventilation, 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 0.025-0.05 ml/kg/h from study recruitment in the ICU during mechanical ventilation, 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 after surgery;
• with an expected duration of mechanical ventilation of more than 12 hours (admitted before 21:00 on the day of surgery and extubated after 06:00 on the first day after surgery).

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), or second degree or greater atrioventricular block without pacemaker, systolic blood pressure less than 90 mmHg despite continuous infusions of vasopressors before the start of study drugs infusion;
• serious hepatic dysfunction (Child-Pugh class C);
• serious renal dysfunction (undergoing dialysis before surgery);
• less likelihood to survive for more than 24 hours;
• preoperative history of sleep disorders (requirement of hypnotics/sedatives during the last month) or history of obstructive sleep apnea syndrome (diagnosed with obstructive sleep apnea);
• allergy to the study drugs;
• other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

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: November 2, 2017
• First Posted: November 7, 2017
• Study Start: November 17, 2017
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)