Brain Neoplasms Clinical Trial
Official title:
The Effect of Dexmedetomidine as an Adjuvant to General Anesthesia on Intelligence Development in Pediatric Patients Undergoing Craniotomy: a Randomized, Double-blind and Placebo-controlled Pilot Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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