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NCT Number: NCT02810899

Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy

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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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

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

Other names: 0.9% sodium chloride

Primary outcomes

  1. Intelligence Quotient

    Time frame: At 3 months after surgery

    Tested with Chinese Binet Intelligence Scale

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Tiantan Hospital

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2016
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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