Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborator: Beijing Tiantan Hospital
• Treatments: Dexmedetomidine

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.