Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery
Condition: Aged; Operative; Delirium; Dexmedetomidine; Mortality; Long-term Survivors
MeSH terms: Delirium
Study type: Interventional

Summary: 
      Delirium is a frequent postoperative complication. Its occurrence is associated with worse
      long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose
      dexmedetomidine infusion during the early postoperative period decreased the incidence of
      delirium in elderly patients after surgery. The purpose of this 5-year follow-up study is to
      evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 5-year
      outcomes in elderly patients recruited in the previous randomized controlled trial.
    

Detailed description: 
      Delirium is a frequent postoperative complication; a systematic review revealed that
      postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases
      with age. The occurrence of delirium is associated with worse long-term outcomes including
      worse functional recovery, decline in cognitive function, and increased mortality rate.
      Surgical stress, pain, and sleep disturbances are important factors leading to postoperative
      delirium in the elderly.

      Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides
      anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For
      mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves
      the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU
      stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of
      stress response, decreases the requirement of anesthetics, and improves postoperative
      analgesia.

      In the previous stage of the current study, 700 elderly patients who were admitted to the ICU
      after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group
      and placebo [normal saline] group). The results showed that prophylactic low-dose
      dexmedetomidine infusion during the early postoperative period ameliorated the subjective
      sleep quality and decreased the incidence of delirium (22.6% [79/350] with placebo vs. 9.1%
      [32/350] with dexmedetomidine; odds ratio 0.35, 95% confidence interval 0.22 to 0.54; p <
      0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also
      improve long-term outcome in this patient population.

      The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose
      dexmedetomidine infusion during the early postoperative period can improve the 5-year
      outcomes in elderly patients recruited in the previous randomized controlled trial.
    

Intervention name(s): dexmedetomidine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): low-dose dexmedetomidine infusion; normal saline infusion
Other intervention name(s): dexmedetomidine hydrochloride; normal saline; 0.9% sodium chloride
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: aged; operative; delirium; dexmedetomidine; long-term outcome