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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
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Drug: dexmedetomidine Drug: normal saline Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: dexmedetomidine
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




Primary Outcome Measures :
  1. Intelligence Quotient [ Time Frame: At 3 months after surgery ]
    Tested with Chinese Binet Intelligence Scale


Secondary Outcome Measures :
  1. Time to anesthesia emergence [ Time Frame: From end of surgery until reappearance of response to oral orders, assessed up to 24 hours ]
  2. Time to extubation [ Time Frame: From end of surgery until extubation, assessed up to 24 hours ]
  3. Depth of sedation at the time of extubation [ Time Frame: Immediately after extubation ]
    Assessed with Ramsay sedation scale

  4. Emergence agitation [ Time Frame: From end of surgery until extubation, assessed up to 24 hours ]
    Agitation will be assessed with anesthesia emergence agitation score.


Other Outcome Measures:
  1. Length of stay in hospital after surgery [ Time Frame: From end of surgery to 30 days after surgery ]
  2. Incidence of postoperative complications [ Time Frame: From end of surgery to 30 days after surgery ]
  3. All-cause 30-day mortality [ Time Frame: At the time of 30 days after surgery ]
  4. All-cause 90-day mortality [ Time Frame: At the time of 90 days after surgery ]


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Beijing
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

Publications:

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Responsible Party: Dong-Xin Wang, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02810899     History of Changes
Other Study ID Numbers: 2015[969]
ChiCTR-IPR-15007085 ( Other Identifier: Chinese Clinical Trial Registry )
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dong-Xin Wang, Peking University First Hospital:
child
craniotomy
intelligence tests
dexmedetomidine
Disruption
Dehiscence
Mild Cognitive Disorder

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action