Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy

NCT ID: NCT02810899

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Brain Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

dexmedetomidine

Intervention Type: 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.

Control group

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

normal saline

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

Intervention Type: DRUG

Other Intervention Names

dexmedetomidine hydrochloride; 0.9% sodium chloride

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong-Xin Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Xin Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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

Beijing, Beijing Municipality, China

Countries

China

References

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Other Identifiers

ChiCTR-IPR-15007085

Identifier Type: OTHER

Identifier Source: secondary_id

2015[969]

Identifier Type: -

Identifier Source: org_study_id