UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009869
Receipt number R000011562
Scientific Title Usefulness of dexmedetomidine for prevention of emergent agitation in infants undergoing palatoplasty
Date of disclosure of the study information 2013/01/25
Last modified on 2013/01/25 10:51:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Usefulness of dexmedetomidine for prevention of emergent agitation in infants undergoing palatoplasty

Acronym

Usefulness of dexmedetomidine

Scientific Title

Usefulness of dexmedetomidine for prevention of emergent agitation in infants undergoing palatoplasty

Scientific Title:Acronym

Usefulness of dexmedetomidine

Region

Japan


Condition

Condition

cleft palate

Classification by specialty

Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The incidence of emergent agitation (EA) after sevoflurane (Sev) anesthesia is high in infants. Although opioids are often used for pain control and to reduce the incidence and severity of EA, anesthesiologists must pay attention to the risk of postoperative resiratory complications. This is particularly important in infants undergoing palatoplasty because edema at the operative site leads to obstructive symptoms and hypoxemia. Dexmedetomidine (Dex) has sedative and analgesic properties without respiratory depression. Some studies have shown the effectiveness of Dex in postoperative recovery, however, the usefulness of Dex in infants undergoing palatoplasty has not yet been well established. We designed a prospective, double-blind, randomized control study to determine the effects of Dex on postoperative recovery in infants undergoing palatoplasty.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To determine the effects of Dex on postoperative recovery in infants undergoing palatoplasty.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In the Dex group, Dex was given from about 10 minutes before the end of the operation.

Interventions/Control_2

In the saline group, the equivalent amount of saline was administered in the same manner.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

10 months-old <=

Age-upper limit

14 months-old >=

Gender

Male and Female

Key inclusion criteria

Participants were required to be ASA physical status class1, aged 10 to 14 months years old, weight between 7 and 10 kg, and have a height between 70 and 80 cm.

Key exclusion criteria

Exclusion criteria included patient refusal, ASA class2, cardiovascular disease, or allergy.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Boku Aiji

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Dental Anesthesiology

Zip code


Address

1-8, Yamadaoka, Suita, Japan

TEL

06-6879-2972

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Dental Anesthesiology

Zip code


Address


TEL


Homepage URL


Email

si-soumu-syomu@office.osaka-u.ac.j


Sponsor or person

Institute

Osaka University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Osaka University Graduate School of Dentistry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 08 Month 23 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 25 Day

Last modified on

2013 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011562


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name