UMIN-CTR Clinical Trial

Public title

Radamized controlled trial ofremifentanil and propofol for nasotrachealintubation condition without the use of muscle
relaxants

Acronym

Study of remifentanil and propofol for nasotrachealintubation without the use
of muscle relaxants

Scientific Title

Radamized controlled trial ofremifentanil and propofol for nasotrachealintubation condition without the use of muscle
relaxants

Scientific Title:Acronym

Study of remifentanil and propofol for nasotrachealintubation without the use
of muscle relaxants

Region

Japan

Condition

Patients of nasotracheal intubation for general anesthesia.

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The necessity of neuromuscular blocking drug for nasotracheal intubation case when Remifentanil and propofol anesthesia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

It classifies according to three steps for difficulty of laryngoscopy, state of vocal cords during intubation and body movement when intubation and cuff infration.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Remifentanil 0.5microg/kg/min and Propofol0.5mg/kg is prescribed for the patient, and anesthesia induction is carried out by propofol 5.0mg/kg/h after that. An isotonic sodium chloride solution is prescribed for the patient, and nasal intubation is carried out 10 minutes after a remifentanil start. The isotonic sodium chloride solution medication which is equivalent to sugamadex 2mg/kg at the time of the end of an operation is prescribed for the patient.

Interventions/Control_2

Introductory
Remifentanil 0.5microg/kg/min and Propofol0.5mg/kg is prescribed for the patient, and anesthesia induction is carried out by propofol 5.0mg/kg/h after that.
Rocuronium 0.6mg/ kg medication is carried out, and nasal intubation is carried out 10 minutes after a remifentanil start. Sugamadex2mg/kg is prescribed for the patient at the time of the end of an operation.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patient who had exodontia, a jaw cyst extirpation, and orthognathic surgery planned under general anesthesia.

Key exclusion criteria

BMI score are 25 or more patients.
They are three or more patients in Mallampati score.
The amount of openings is a patient of less than 3.5 cm.
A patient who has a cervical vertebrae disease.
They are three or more patients in Cormack and Lehane score.
A patient who has two or more cardiopathy by the heartbeat classification of NYHA.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Katsuhisa Sunada

Organization

The Nippon Dental University school of Life Dentistry at Tokyo

Division name

Department of Dental Anesthesiology The Nippon Dental University school of Life Dentistry at Tokyo

Zip code

Address

1-9-20Fujimi,Chiyoda-ku,Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

The Nippon Dental University school of Life Dentistry at Tokyo

Division name

Department of Dental Anesthesiology The Nippon Dental University school of Life Dentistry at Tokyo

Zip code

Address

1-9-20Fujimi,Chiyoda-ku,Tokyo

TEL

Homepage URL

Email

Institute

The Nippon Dental University school of Life Dentistry at Tokyo

Institute

Department

Personal name

Organization

The Nippon Dental University school of Life Dentistry at Tokyo

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012

Year

11

Month

22

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

22

Day

Last modified on

2012

Year

11

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008103