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

NCT01353378 | Withdrawn Phase 4 DMC

• 1 other identifier: JYMZK-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

dexmedetomidine; emergence delirium; sevoflurane anesthesia; preschool children; oral maxillofacial surgery

Outcome Measures

Primary Outcomes (1)

• post anesthesia emergence delirium scale(PAED scale)

  evaluate children's PAED scale score 2 hours post-surgery

  2 hours post-surgery

Secondary Outcomes (1)

• Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)

  2 hours post-surgery

Study Arms (1)

dexmedetomidine

EXPERIMENTAL

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

Drug: dexmedetomidine

Interventions

dexmedetomidine 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.

Also known as: dexmedetomidine hydrochloride injection

dexmedetomidine

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• preschool children undergoing oral maxillofacial surgery

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Delirium; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hong Jiang, MD, PHD

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

  STUDY DIRECTOR

• Rong Hu, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending in anesthesiology department

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: May 13, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

CN (1)