Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT02810899
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.
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Notify Me2 year–12 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: dexmedetomidine hydrochloride
Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group
Other names: 0.9% sodium chloride
Time frame: At 3 months after surgery
Tested with Chinese Binet Intelligence Scale
Time frame: From end of surgery until reappearance of response to oral orders, assessed up to 24 hours
Time frame: From end of surgery until extubation, assessed up to 24 hours
Time frame: Immediately after extubation
Assessed with Ramsay sedation scale
Time frame: From end of surgery until extubation, assessed up to 24 hours
Agitation will be assessed with anesthesia emergence agitation score.
Time frame: From end of surgery to 30 days after surgery
Time frame: From end of surgery to 30 days after surgery
Time frame: At the time of 30 days after surgery
Time frame: At the time of 90 days after surgery
Peking University First Hospital
Other
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
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