Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy

September 28, 2016 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intelligence Quotient
Time Frame: At 3 months after surgery
Tested with Chinese Binet Intelligence Scale
At 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to anesthesia emergence
Time Frame: From end of surgery until reappearance of response to oral orders, assessed up to 24 hours
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
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
Immediately after extubation
Emergence agitation
Time Frame: From end of surgery until extubation, assessed up to 24 hours
Agitation will be assessed with anesthesia emergence agitation score.
From end of surgery until extubation, assessed up to 24 hours

Other Outcome Measures

Outcome Measure
Time Frame
Length of stay in hospital after surgery
Time Frame: From end of surgery to 30 days after surgery
From end of surgery to 30 days after surgery
Incidence of postoperative complications
Time Frame: From end of surgery to 30 days after surgery
From end of surgery to 30 days after surgery
All-cause 30-day mortality
Time Frame: At the time of 30 days after surgery
At the time of 30 days after surgery
All-cause 90-day mortality
Time Frame: At the time of 90 days after surgery
At the time of 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015[969]
  • ChiCTR-IPR-15007085 (Other Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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