Patients Under Hip, Femur, Spine Operation Clinical Trial
Official title:
Effect of Dexmedetomidine on Postoperative Delirium Inflammasome Activation Inhibition
| Verified date | February 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Delirium is an acute or subacute comorbid syndrome characterized by decreased awareness and
cognitive dysfunction accompanied by attention deficit. It varies from 20% to 80%, depending
on the report. If delirium occurs in intensive care unit, complications such as intubation
tube and catheter removal that are not desired are increased, mechanical ventilation
deviation is prolonged, and eventually the intensive care unit is extended. Prevention of
delirium is therefore very important, but no medication has been found to prevent delirium.
Recent studies have shown that pro-inflammatory cytokines play an important role in the
development of delirium, and as a result of the stimulation of the peripheral inflammatory
reaction, proinflammatory cytokines (interleukin (IL) -6, tumor necrosis factor- ), And
IL-10) secretion, resulting in the induction of inflammatory responses of the central nervous
system. In addition, sleep habits have been shown to affect the pro-inflammatory pathway, and
sleep induction and inactivation of the pro-inflammatory pathway may be expected to prevent
and treat delirium.
Dexmedetomidine (DEX) is a highly selective a2-agonist with sedative and analgesic effects
and reduces sympathetic response to stimuli. Compared to benzodiazepine and opioid, there are
fewer side effects of respiratory depression.
In animal studies, the possibility of intrinsic immune suppression of DEX has been
demonstrated, and recent studies have shown that intravenous DEX administration reduces IL-6,
IL-8, and TNF-a levels, resulting in anti-inflammatory effects. IL-6 plays a key role in
neuroinflammation with both proinflammatory cytokines and anti-inflammatory cytokines,
including infection, traumatic brain injury, ischemia, and neurodegenerative disorders. DEX
plays a key role in IL-6 stimulated IL-6 And inhibits mRNA expression and thus has a brain
function-protecting effect. In clinical trials, DEX administration compared with propofol
decreased IL-6 secretion and decreased post-operative cognitive impairment in ICU patients
after primary surgery. This is closely related to the formation of inflammatory complexes
(Inflammasome). In addition, low-dose DEX infusion in patients with ICU at night has a low
incidence of delirium during the ICU period, and studies have shown that sleep quality is
improved in the DEX group in the mechanical ventilation group. Patients who did not undergo
mechanical ventilation also reported improved sleep quality with prophylactic low-dose DEX.
As such, the definitive mechanism has not yet been clarified, but the use of low-dose DEX is
increasingly proactively used to improve sleep quality.
The purpose of this study was to investigate the effect of DEX on the inflammatory pathway
during nighttime after ICU admission and to observe the quality of sleep and the prognosis of
delirium.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | July 2019 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - ASA class I to III adults - aged 20 years or older who can read and understand the consent form - patients who have been admitted to the ICU after institution of hip, femur, and spine surgery Exclusion Criteria: - Patients who do not understand and understand the written consent of an illiterate or foreigner - pregnant woman - 20 years old - Patients with moderate to severe liver disease (AST, ALT> 200 IU / L) - Patients with end stage renal disease (eGFR <30 or dialysis patients) - allergy to DEX, presence of electrocardiographic atrioventricular block, hemodynamic instability - Left ventricular ejection fraction <30%, congestive heart failure, severe coronary artery disease, hemodynamically unstable arrhythmia |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CRP(C-reactive protein) | Effect of dexmedetomidine(DEX) on post-conditioning delirium and inflammasome activation | Post operative day 0 | |
| Primary | CRP(C-reactive protein) | Effect of dexmedetomidine(DEX) on post-conditioning delirium and inflammasome activation | Post operative day 1 | |
| Primary | the number of Neutrophil or Lymphocyte | Effect of dexmedetomidine(DEX) on post-conditioning delirium and inflammasome activation | Post operative day 0 | |
| Primary | the number of Neutrophil or Lymphocyte | Effect of dexmedetomidine(DEX) on post-conditioning delirium and inflammasome activation | Post operative day 1 | |
| Primary | total score of Richards-Campbell Sleep Questionnaire(RCSQ) obtained by summing each score out of 100 | double-checked RCSQ; one is patient check, and the other is night nurse check. | Post operative day 0 | |
| Primary | total score of Richards-Campbell Sleep Questionnaire(RCSQ) obtained by summing each score out of 100 | double-checked RCSQ; one is patient check, and the other is night nurse check. | Post operative day 1 |