Mechanical Ventilation Complication Clinical Trial
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05030337 -
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
|
N/A | |
| Completed |
NCT05144607 -
Impact of Inspiratory Muscle Pressure Curves on the Ability of Professionals to Identify Patient-ventilator Asynchronies
|
N/A | |
| Recruiting |
NCT03697785 -
Weaning Algorithm for Mechanical VEntilation
|
N/A | |
| Completed |
NCT05084976 -
Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
|
||
| Active, not recruiting |
NCT05886387 -
a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
|
||
| Completed |
NCT04429399 -
Lowering PEEP: Weaning From High PEEP Setting
|
N/A | |
| Completed |
NCT02249039 -
Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study
|
Phase 1 | |
| Recruiting |
NCT02071524 -
Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics
|
N/A | |
| Completed |
NCT01114022 -
Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane
|
N/A | |
| Completed |
NCT00893763 -
Strategies To Prevent Pneumonia 2 (SToPP2)
|
Phase 2 | |
| Terminated |
NCT05056103 -
Automated Secretion Removal in ICU Patients
|
N/A | |
| Active, not recruiting |
NCT04558476 -
Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation
|
Phase 2 | |
| Recruiting |
NCT05295186 -
PAV Trial During SBT Trial
|
||
| Active, not recruiting |
NCT05370248 -
The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient
|
N/A | |
| Completed |
NCT04818164 -
Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
|
||
| Completed |
NCT04589910 -
Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.
|
N/A | |
| Completed |
NCT04193254 -
LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
|
||
| Not yet recruiting |
NCT03259854 -
Non Invasive Mechanical Ventilation VERSUS Oxygen MASK
|
N/A | |
| Not yet recruiting |
NCT03245684 -
Assisted or Controlled Ventilation in Ards (Ascovent)
|
N/A | |
| Completed |
NCT06332768 -
NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients
|
N/A |