Clinical trial · Interventional
Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy
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
NCT02810899CI-TRIAL-00024093completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexmedetomidine | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dexmedetomidine group
- description
- 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.
- interventionNames
- Drug: dexmedetomidine
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Normal saline will be administered in the same rate and volume as that in the dexmedetomidine group.
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- Intelligence Quotient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 2 years or older, but no more than 12 years; 2. Plan to undergo selective craniotomy under general anesthesia for intracranial tumor resection; 3. Written informed consent signed by legal guardians. Exclusion Criteria: 1. Refused to participate by the legal guardians; 2. Body weight lower than the 3rd percentile or higher than 97th percentile of the normal body weight reference; 3. American Society of Anesthesiologists physical classification of IV or higher; 4. Unable to complete preoperative intelligence assessment because of coma, dysnoesia, or language barrier; 5. Diagnosed pulmonary disease (including acute respiratory tract infection) or cardiovascular disease (including congenital heart disease, hypertension, hypotension, bradycardia, atrioventricular block, or cardiac insufficiency); 6. Abnormal liver or renal function (liver enzyme or creatinine higher than 1.5 times of the upper normal limit; 7. Other congenital diseases that may affect the development of the nervous system (such as Down's Syndrome); 8. Allergy to dexmedetomidine; 9. Other conditions that are considered unsuitable for study participation by the attending pediatricians or investigators.
References
Publications (11)
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- BACKGROUNDOlney JW, Ishimaru MJ, Bittigau P, Ikonomidou C. Ethanol-induced apoptotic neurodegeneration in the developing brain. Apoptosis. 2000 Dec;5(6):515-21. doi: 10.1023/a:1009685428847. PMID 11303910
- BACKGROUNDJevtovic-Todorovic V, Absalom AR, Blomgren K, Brambrink A, Crosby G, Culley DJ, Fiskum G, Giffard RG, Herold KF, Loepke AW, Ma D, Orser BA, Planel E, Slikker W Jr, Soriano SG, Stratmann G, Vutskits L, Xie Z, Hemmings HC Jr. Anaesthetic neurotoxicity and neuroplasticity: an expert group report and statement based on the BJA Salzburg Seminar. Br J Anaesth. 2013 Aug;111(2):143-51. doi: 10.1093/bja/aet177. Epub 2013 May 30. PMID 23722106
- BACKGROUNDPoggi G, Liscio M, Galbiati S, Adduci A, Massimino M, Gandola L, Spreafico F, Clerici CA, Fossati-Bellani F, Sommovigo M, Castelli E. Brain tumors in children and adolescents: cognitive and psychological disorders at different ages. Psychooncology. 2005 May;14(5):386-95. doi: 10.1002/pon.855. PMID 15386759
- BACKGROUNDHernandez MT, Sauerwein HC, Jambaque I, de Guise E, Lussier F, Lortie A, Dulac O, Lassonde M. Attention, memory, and behavioral adjustment in children with frontal lobe epilepsy. Epilepsy Behav. 2003 Oct;4(5):522-36. doi: 10.1016/j.yebeh.2003.07.014.