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

December 10, 2019 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
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 Names:
  • 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
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 Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at 08:00 on the first day after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Assessed twice daily during the first 7 days after surgery.
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).
Assessed once daily during the first 7 days after surgery.
Total sleep time
Time Frame: Monitored with polysomnograph during the night of surgery.
Total sleep time
Monitored with polysomnograph during the night of surgery.
Sleep efficiency
Time Frame: Monitored with polysomnograph during the night of surgery.
Sleep efficiency
Monitored with polysomnograph during the night of surgery.
Fragmented sleep index
Time Frame: Monitored with polysomnograph during the night of surgery.
Fragmented sleep index
Monitored with polysomnograph during the night of surgery.
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.
Monitored with polysomnograph during the night of surgery.
Duration of mechanical ventilation.
Time Frame: From ICU admission to 30 days after surgery.
Duration of mechanical ventilation.
From ICU admission to 30 days after surgery.
Length of stay in the ICU.
Time Frame: From ICU admission to 30 days after surgery.
Length of stay in the ICU.
From ICU admission to 30 days after surgery.
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.
From date of surgery to 30 days after surgery.
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.
From date of surgery to 30 days after surgery.
All-cause 30-day mortality.
Time Frame: On the 30th day after surgery.
All-cause 30-day mortality.
On the 30th day after surgery.
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.
On the 30th day after surgery.
30-day quality of life.
Time Frame: On the 30th day after surgery.
Assessment with WhoQOL-Bref.
On the 30th day after surgery.
30-day sleep quality.
Time Frame: On the 30th day after surgery.
Assessment with Pittsburgh Sleep Quality Index (PSQI).
On the 30th day after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed during the first 7 days after surgery.
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).
Assessed within 24 hours after ICU admission.
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.
During mechanical ventilation, for a maximum of 3 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2017

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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