Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy
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|ClinicalTrials.gov Identifier: NCT02810899|
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms||Drug: dexmedetomidine Drug: normal saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Dexmedetomidine group
A loading dose of dexmedetomidine (0.5 ug/kg IV infusion in 15 minutes) will be administered after induction of general anesthesia, followed by continuous infusion at a rate of 0.5 ug/kg/h until the closure of the duramater of the brain.
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 Name: dexmedetomidine hydrochloride
Placebo Comparator: Control group
Normal saline will be administered in the same rate and volume as that in the dexmedetomidine group.
Drug: normal saline
Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group
Other Name: 0.9% sodium chloride
- Intelligence Quotient [ Time Frame: At 3 months after surgery ]Tested with Chinese Binet Intelligence Scale
- Time to anesthesia emergence [ Time Frame: From end of surgery until reappearance of response to oral orders, assessed up to 24 hours ]
- Time to extubation [ Time Frame: From end of surgery until extubation, assessed up to 24 hours ]
- Depth of sedation at the time of extubation [ Time Frame: Immediately after extubation ]Assessed with Ramsay sedation scale
- Emergence agitation [ Time Frame: From end of surgery until extubation, assessed up to 24 hours ]Agitation will be assessed with anesthesia emergence agitation score.
- Length of stay in hospital after surgery [ Time Frame: From end of surgery to 30 days after surgery ]
- Incidence of postoperative complications [ Time Frame: From end of surgery to 30 days after surgery ]
- All-cause 30-day mortality [ Time Frame: At the time of 30 days after surgery ]
- All-cause 90-day mortality [ Time Frame: At the time of 90 days after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810899
|Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital|
|Beijing, Beijing, China, 100034|
|Principal Investigator:||Dong-Xin Wang, MD, PhD||Peking University First Hospital|