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

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ClinicalTrials.gov Identifier: NCT03335527
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Aged Postoperative Period Intensive Care Units Mechanical Ventilation Complication Sleep Disorders Dexmedetomidine Drug: Dexmedetomidine Drug: Placebo (normal saline) Phase 4

Detailed Description:

Sleep is severely disturbed in mechanically ventilated ICU patients, especially those after surgery. Polysomnographic studies performed in these patients demonstrated a severe increase in sleep fragmentation, prolonged N1 and N2 sleep, reduced N3 and REM sleep, and an abnormal distribution of sleep because almost half of the total sleep time occurred during the daytime. Patients reported little or no sleep, poor sleep quality, frequent awakening, and daytime sleep.

Many factors are responsible for sleep disturbance in postoperative ICU patients with mechanical ventilation, these include the severity of surgical stress and illness, ICU environment, mechanical ventilation, pain, sedatives and analgesics, and various other therapy. Sleep disturbances produce harmful effects on postoperative outcomes. It is associated with increased prevalence of delirium, cardiac events and worse functional recovery. Moreover, patients with sleep disturbances are more sensitive to pain.

Unlike other sedative agents, dexmedetomidine exerts its sedative effects through an endogenous sleep-promoting pathway and produces a N2 sleep-like state. In mechanically ventilated ICU patients, nighttime infusion of sedative dose of dexmedetomidine (median 0.6 microgram/kg/h) preserved the day-night cycle of sleep and improved the sleep architecture by increasing sleep efficiency and stage N2 sleep.

Studies showed that, in mechanically ventilated patients, light sedation is better than deep sedation for patients' outcomes, including shortened duration of ventilation and length of ICU stay, and decreased mortality. Some studies even showed that no sedation (analgesia only) is better than sedation. In a recent study of non mechanical ventilated elderly patients who were admitted to the ICU after surgery, non-sedative low-dose dexmedetomidine infusion (at a rate of 0.1 microgram/kg/h during the night on the day of surgery) increased the percentage of stage N2 sleep (and decreased the percentage of N1 sleep), prolonged the total sleep time, increased the sleep efficiency, and improved the subjective sleep quality.

The investigators hypothesize that, in mechanically ventilated patients who were admitted to the ICU after surgery, low-dose dexmedetomidine infusion may also improve sleep quality.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Low-Dose Dexmedetomidine on Sleep Quality in Mechanical Ventilation Patients After Surgery in Intensive Care Unit: a Pilot Randomized, Double-Blind, Placebo-Controlled Trial
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine group
Dexmedetomidine is infused at a rate of 0.1 ug/kg/h during mechanical ventilation, for a maximum of 3 days
Drug: Dexmedetomidine
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.
Other Name: Dexmedetomidine hydrochloride

Placebo Comparator: Placebo group
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)
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.
Other Name: Normal saline




Primary Outcome Measures :
  1. Sleep quality during the night of surgery. [ Time Frame: Assessed at 08:00 on the first day after surgery. ]
    Sleep quality assessed with Richards-Campbell Sleep Questionnaire at 08:00 on the first day after surgery.


Secondary Outcome Measures :
  1. Incidence of delirium within the first 7 days after surgery. [ Time Frame: Assessed twice daily during the first 7 days after surgery. ]
    Assessment twice daily (in the morning from 06:00 to 10:00 and in the evening from 18:00 to 20:00) with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

  2. Sleep quality within the first 7 days after surgery. [ Time Frame: Assessed once daily during the first 7 days after surgery. ]
    Assessment once daily (at 08:00) with Richards-Campbell Sleep Questionnaire (RCSQ).

  3. Total sleep time [ Time Frame: Monitored with polysomnograph during the night of surgery. ]
    Total sleep time

  4. Sleep efficiency [ Time Frame: Monitored with polysomnograph during the night of surgery. ]
    Sleep efficiency

  5. Fragmented sleep index [ Time Frame: Monitored with polysomnograph during the night of surgery. ]
    Fragmented sleep index

  6. Percentages of sleep stages [ Time Frame: Monitored with polysomnograph during the night of surgery. ]
    Percentages of stage 1 non-rapid sleep movement sleep (N1), N2, N3 and rapid eye movement (REM) sleep.

  7. Duration of mechanical ventilation. [ Time Frame: From ICU admission to 30 days after surgery. ]
    Duration of mechanical ventilation.

  8. Length of stay in the ICU. [ Time Frame: From ICU admission to 30 days after surgery. ]
    Length of stay in the ICU.

  9. Length of stay in the hospital after surgery. [ Time Frame: From date of surgery to 30 days after surgery. ]
    Length of stay in the hospital after surgery.

  10. Occurrence of postoperative complications. [ Time Frame: From date of surgery to 30 days after surgery. ]
    Occurrence of complications other than delirium within 30 days after surgery.

  11. All-cause 30-day mortality. [ Time Frame: On the 30th day after surgery. ]
    All-cause 30-day mortality.

  12. 30-day cognitive function. [ Time Frame: On the 30th day after surgery. ]
    Assessment with Telephone Interview for Cognitive Status-modified (TICS-m) in 30-day survivors.

  13. 30-day quality of life. [ Time Frame: On the 30th day after surgery. ]
    Assessment with WhoQOL-Bref.

  14. 30-day sleep quality. [ Time Frame: On the 30th day after surgery. ]
    Assessment with Pittsburgh Sleep Quality Index (PSQI).


Other Outcome Measures:
  1. Pain intensity. [ Time Frame: Assessed during the first 7 days after surgery. ]
    Assessment twice daily (in the morning from 06:00 to 10:00 and in the evening from 18:00 to 20:00) with the Numeric Rating Scale (NRS, an 11 point scale where 0 indicated no pain and 10 indicated the worst possible pain) at movement or the Behavior Pain Scale (BPS, an 12 point scale where 3 indicated no pain and 12 indicated the worst possible pain) at rest.

  2. Score of Acute Physiology and Chronic Health Evaluation II (APACHE II). [ Time Frame: Assessed within 24 hours after ICU admission. ]
    Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).

  3. Percentage of time within the target of sedation during mechanical ventilation. [ Time Frame: During mechanical ventilation, for a maximum of 3 days. ]
    Percentage of time within the target of sedation (Richmond Agitation-Sedation Scale -1~-2) during mechanical ventilation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335527


Locations
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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications:

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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03335527    
Other Study ID Numbers: 2017[13]
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Aged
Postoperative period
Intensive Care Unit
Mechanical ventilation
Sleep quality
Dexmedetomidine
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action