Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium

NCT ID: NCT01353378

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.

Detailed Description

Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.

Conditions

Delirium

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

dexmedetomidine

intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively.

Group Type: EXPERIMENTAL

dexmedetomidine

Intervention Type: DRUG

Intravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes.

Interventions

dexmedetomidine

Intravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes.

Intervention Type: DRUG

Other Intervention Names

dexmedetomidine hydrochloride injection

Eligibility Criteria

Inclusion Criteria

• preschool children undergoing oral maxillofacial surgery

Exclusion Criteria

• mental diseases
• history of neural system disease
• sedative medication history
• anticipated difficult airway

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Rong Hu

attending in anesthesiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Jiang, MD, PHD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Rong Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Locations

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

JYMZK-001

Identifier Type: -

Identifier Source: org_study_id