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

Primary Purpose

Delirium

Status

Withdrawn

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

dexmedetomidine

About this trial

This is an interventional supportive care trial for Delirium focused on measuring dexmedetomidine, emergence delirium, sevoflurane anesthesia, preschool children, oral maxillofacial surgery

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

preschool children undergoing oral maxillofacial surgery

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dexmedetomidine

Arm Description

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

Outcomes

Primary Outcome Measures

post anesthesia emergence delirium scale(PAED scale)

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01353378

First Posted

April 21, 2011

Last Updated

May 2, 2017

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01353378

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Withdrawn

Why Stopped

The study was not approved by Hospital's Medical Ethics Committee.

Study Start Date

June 2011 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine

Other Intervention Name(s)

dexmedetomidine hydrochloride injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

post anesthesia emergence delirium scale(PAED scale)

Description

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

Time Frame

2 hours post-surgery

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 hours post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hong Jiang, MD, PHD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rong Hu, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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