Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy
Condition: Brain Neoplasms
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, double-blind and placebo-controlled pilot study is to
      investigate whether dexmedetomidine when used as an adjuvant to general anesthesia can
      decrease the harmful effects of anesthesia and surgery on intelligence development in
      pediatric patients undergoing craniotomy.
    

Detailed description: 
      General anesthetics and sedatives are administered to millions of children each year to
      facilitate life-saving surgery and other essential surgical or medical procedures. In the
      past two decades, mounting evidence from animal and clinical studies have raised concerns
      that general anesthetics may produce harmful effects in the developing brain and lead to
      adverse neurodevelopmental outcomes. Factors that may influence the degree of injury include
      age at the time of drug exposure/surgery and cumulative anesthetic dose.

      The Intelligence Quotients of pediatric patients with intracranial tumors are lower when
      compared with healthy children of same age. The investigators suppose that these patients are
      more sensitive to the neurotoxic effects of general anesthetics. Dexmedetomidine is an alpha
      2-adrenoceptor agonist that provides sedation, anxiolysis, and analgesia, and has been shown
      to be safe to the brain in animal studies. In clinical studies, the use of dexmedetomidine
      decreases the consumption of anesthetics and opioids during general anesthesia and suppresses
      stress response induced by surgery. The investigators hypothesize that dexmedetomidine, when
      used as an adjuvant to general anesthesia, can reduce the neurotoxic effects of general
      anesthetics by decreasing anesthetic consumption and inhibiting stress response.

      The purpose of this randomized, double-blind and placebo-controlled pilot study is to
      investigate whether dexmedetomidine, when used as an adjuvant to general anesthesia, can
      decrease the harmful effects of anesthesia and surgery on intelligence development of
      pediatric patients undergoing craniotomy.
    

Intervention name(s): dexmedetomidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): A loading dose dexmedetomidine (0.5 ug/kg IV infused in 15 minutes) will be administered after anesthesia induction, followed by a continuous infusion at a rate of 0.5 ug/kg/h until the closure of the brain duramater at the end of surgery.; Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group
Other intervention name(s): dexmedetomidine hydrochloride; 0.9% sodium chloride
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: child; craniotomy; intelligence tests; dexmedetomidine; Disruption; Dehiscence; Mild Cognitive Disorder