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The effect of dexmedetomidine as an adjuvant to general anesthesia on intelligence of pediatric patients after craniotomy: a randomized, prospective, double-blind placebo-controlled pilot study

The effect of dexmedetomidine as an adjuvant to general anesthesia on intelligence of pediatric patients after craniotomy: a randomized,prospective, double-blind placebo-controlled pilot studyPatients Undergoing Craniotomy-a Prospective Double-blinded Randomized Placebo-controlled Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007085
Enrollment
Unknown
Registered
2015-09-01
Start date
2015-09-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracranial tumor

Interventions

experiment group:Dexmedetomidine
Control:Placebo

Sponsors

Anaesthesiology Department,Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Age of 2 years old or more, but not more than 12 years old; (2) Plan to undergo selective craniotomy under general anesthesia for tumor resection; (3) Written informed consent signed by legal guardians.

Exclusion criteria

Exclusion criteria: (1) Refused to participate by the legal guardians; (2) Body weight lower than the 3rd percentile references or higher than 97th percentile references of the body weight developed for aged 2-18 years old; (3) ASA 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 acuteper 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 theper normal limit; (7) Other congenital diseases that may affect the development of the nervous tem (such as Down Syndrome); (8) Allergy to dexmedetomidine; (9) Other conditions that are considered unsuitable for study participation by the attending pediatricians or investigators.

Design outcomes

Primary

MeasureTime frame
Intelligence quotient;

Secondary

MeasureTime frame
Time to emergence;Time to extubation;Consumption of general anesthetics;Depth score of sedation;Emergence agitation;intraoperative adverse events;Length of stay in hospital after surgery;all-cause mortality;

Countries

China

Contacts

Public ContactWang Dongxin
wangdongxin@hotmail.com+86 13910731903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026