Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT03335527
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (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
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.
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).
Time frame: Assessed once daily during the first 7 days after surgery.
Assessment once daily (at 08:00) with Richards-Campbell Sleep Questionnaire (RCSQ).
Time frame: Monitored with polysomnograph during the night of surgery.
Total sleep time
Time frame: Monitored with polysomnograph during the night of surgery.
Sleep efficiency
Time frame: Monitored with polysomnograph during the night of surgery.
Fragmented sleep index
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.
Time frame: From ICU admission to 30 days after surgery.
Duration of mechanical ventilation.
Time frame: From ICU admission to 30 days after surgery.
Length of stay in the ICU.
Time frame: From date of surgery to 30 days after surgery.
Length of stay in the hospital after surgery.
Time frame: From date of surgery to 30 days after surgery.
Occurrence of complications other than delirium within 30 days after surgery.
Time frame: On the 30th day after surgery.
All-cause 30-day mortality.
Time frame: On the 30th day after surgery.
Assessment with Telephone Interview for Cognitive Status-modified (TICS-m) in 30-day survivors.
Time frame: On the 30th day after surgery.
Assessment with WhoQOL-Bref.
Time frame: On the 30th day after surgery.
Assessment with Pittsburgh Sleep Quality Index (PSQI).
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.
Time frame: Assessed within 24 hours after ICU admission.
Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).
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.
Peking University First Hospital
Other
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
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