NCT02810899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

June 8, 2016

Last Update Submit

September 28, 2016

Conditions

Brain Neoplasms

Keywords

childcraniotomyintelligence testsdexmedetomidineDisruptionDehiscenceMild Cognitive Disorder

Outcome Measures

Primary Outcomes (1)

  • Intelligence Quotient

    Tested with Chinese Binet Intelligence Scale

    At 3 months after surgery

Secondary Outcomes (4)

  • Time to anesthesia emergence

    From end of surgery until reappearance of response to oral orders, assessed up to 24 hours

  • Time to extubation

    From end of surgery until extubation, assessed up to 24 hours

  • Depth of sedation at the time of extubation

    Immediately after extubation

  • Emergence agitation

    From end of surgery until extubation, assessed up to 24 hours

Other Outcomes (4)

  • Length of stay in hospital after surgery

    From end of surgery to 30 days after surgery

  • Incidence of postoperative complications

    From end of surgery to 30 days after surgery

  • All-cause 30-day mortality

    At the time of 30 days after surgery

  • +1 more other outcomes

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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.

Drug: dexmedetomidine

Control group

PLACEBO COMPARATOR

Normal saline will be administered in the same rate and volume as that in the dexmedetomidine group.

Drug: normal saline

Interventions

dexmedetomidineDRUG

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.

Also known as: dexmedetomidine hydrochloride
Dexmedetomidine group
normal salineDRUG

Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group

Also known as: 0.9% sodium chloride
Control group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age of 2 years or older, but no more than 12 years;
  • Plan to undergo selective craniotomy under general anesthesia for intracranial tumor resection;
  • Written informed consent signed by legal guardians.

You may not qualify if:

  • Refused to participate by the legal guardians;
  • Body weight lower than the 3rd percentile or higher than 97th percentile of the normal body weight reference;
  • American Society of Anesthesiologists physical classification of IV or higher;
  • Unable to complete preoperative intelligence assessment because of coma, dysnoesia, or language barrier;
  • Diagnosed pulmonary disease (including acute respiratory tract infection) or cardiovascular disease (including congenital heart disease, hypertension, hypotension, bradycardia, atrioventricular block, or cardiac insufficiency);
  • Abnormal liver or renal function (liver enzyme or creatinine higher than 1.5 times of the upper normal limit;
  • Other congenital diseases that may affect the development of the nervous system (such as Down's Syndrome);
  • Allergy to dexmedetomidine;
  • Other conditions that are considered unsuitable for study participation by the attending pediatricians or investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (11)

  • Rappaport BA, Suresh S, Hertz S, Evers AS, Orser BA. Anesthetic neurotoxicity--clinical implications of animal models. N Engl J Med. 2015 Feb 26;372(9):796-7. doi: 10.1056/NEJMp1414786.

    PMID: 25714157BACKGROUND

  • Cattano D, Young C, Straiko MM, Olney JW. Subanesthetic doses of propofol induce neuroapoptosis in the infant mouse brain. Anesth Analg. 2008 Jun;106(6):1712-4. doi: 10.1213/ane.0b013e318172ba0a.

    PMID: 18499599BACKGROUND

  • Ikonomidou C, Bosch F, Miksa M, Bittigau P, Vockler J, Dikranian K, Tenkova TI, Stefovska V, Turski L, Olney JW. Blockade of NMDA receptors and apoptotic neurodegeneration in the developing brain. Science. 1999 Jan 1;283(5398):70-4. doi: 10.1126/science.283.5398.70.

    PMID: 9872743BACKGROUND

  • Olney 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: 11303910BACKGROUND

  • Jevtovic-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: 23722106BACKGROUND

  • Poggi 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: 15386759BACKGROUND

  • Hernandez 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.

    PMID: 14527495BACKGROUND

  • Wang XW, Cao JB, Lv BS, Mi WD, Wang ZQ, Zhang C, Wang HL, Xu Z. Effect of perioperative dexmedetomidine on the endocrine modulators of stress response: a meta-analysis. Clin Exp Pharmacol Physiol. 2015 Aug;42(8):828-36. doi: 10.1111/1440-1681.12431.

    PMID: 26016707BACKGROUND

  • Li Y, Wang B, Zhang LL, He SF, Hu XW, Wong GT, Zhang Y. Dexmedetomidine Combined with General Anesthesia Provides Similar Intraoperative Stress Response Reduction When Compared with a Combined General and Epidural Anesthetic Technique. Anesth Analg. 2016 Apr;122(4):1202-10. doi: 10.1213/ANE.0000000000001165.

    PMID: 26991622BACKGROUND

  • Kim DJ, Kim SH, So KY, Jung KT. Effects of dexmedetomidine on smooth emergence from anaesthesia in elderly patients undergoing orthopaedic surgery. BMC Anesthesiol. 2015 Oct 7;15:139. doi: 10.1186/s12871-015-0127-4.

    PMID: 26446479BACKGROUND

  • Le Bot A, Michelet D, Hilly J, Maesani M, Dilly MP, Brasher C, Mantz J, Dahmani S. Efficacy of intraoperative dexmedetomidine compared with placebo for surgery in adults: a meta-analysis of published studies. Minerva Anestesiol. 2015 Oct;81(10):1105-17. Epub 2015 May 25.

    PMID: 26005187BACKGROUND

MeSH Terms

Conditions

Brain NeoplasmsNeurocognitive Disorders

Interventions

DexmedetomidineSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Dong-Xin Wang, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 23, 2016

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Locations

CN(1)