UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016722
Receipt number R000019406
Scientific Title Sedation for pharyngeal examination with transoral endoscopy: a comparative study of no sedation, midazolam and pethidine hydrochloride
Date of disclosure of the study information 2015/03/06
Last modified on 2016/01/18 09:00:31

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Basic information

Public title

Sedation for pharyngeal examination with transoral endoscopy: a comparative study of no sedation, midazolam and pethidine hydrochloride

Acronym

Sedation for pharyngeal examination with transoral endoscopy

Scientific Title

Sedation for pharyngeal examination with transoral endoscopy: a comparative study of no sedation, midazolam and pethidine hydrochloride

Scientific Title:Acronym

Sedation for pharyngeal examination with transoral endoscopy

Region

Japan


Condition

Condition

pharyngeal cancer

Classification by specialty

Gastroenterology Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility of midazolam and pethidine hydrochloride for pharyngeal examination

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The score of suitable quality images at the 5 points as follows: uvula, posterior wall of oropharynx, epiglottic vallecula, right pyriform sinus and left pyriform sinus

Key secondary outcomes

Pharyngeal observation time,
Visual analogue scale score for discomfort after the pharyngeal examination


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

no sedation

Interventions/Control_2

midazolam

Interventions/Control_3

pethidine hydrochloride

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with esophageal cancer or patients who have history of esophageal cancer

Key exclusion criteria

Patients with pharyngeal cancer or patients who have history of pharyngeal cancer
Patients with hematological abnormality
Patients with severe organ failure
Patients who have been judged as in appropriate for this study

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryu Ishihara

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gastrointestinal Oncology

Zip code


Address

1-3-3, Higashinari-ku, Osaka 537-8511, Japan

TEL

06-6972-1181

Email

isihara-ry@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Yamasaki

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gastrointestinal Oncology

Zip code


Address

1-3-3, Higashinari-ku, Osaka 537-8511, Japan

TEL

06-6972-1181

Homepage URL


Email

yasshifive@yahoo.co.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Organization

Division

Category of Funding Organization

Self funding

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

2015 Year 03 Month 06 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

2015 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 10 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete

2015 Year 12 Month 31 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 03 Month 06 Day

Last modified on

2016 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name