UMIN-CTR Clinical Trial

Basic information
Public title	comparison of target-controlled and manually-controlled infusion of remifentanil for conscious sedation of awake nasotracheal fiberoptic intubation in patients with maxillofacial surgeries and suspected cervical injurey
Acronym	comparison of target controlled and manually controllef infusion of remifentanil
Scientific Title	comparison of target-controlled and manually-controlled infusion of remifentanil for conscious sedation of awake nasotracheal fiberoptic intubation in patients with maxillofacial surgeries and suspected cervical injurey
Scientific Title:Acronym	comparison of target controlled and manually controllef infusion of remifentanil
Region	Asia(except Japan)

Condition
Condition	traumatic injured patients who need nasotracheal intubation for elective maxillofacial surgery and have documented or suspected cervical spinal injurey
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	vital signs during fiberoptic intubation in 4 data points, intubation condition during procedure,pain and recall 24 h after the procedure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	vital signs during procedure,analgesia and intubation condition
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In group A :target controlled infusion of remifentanil with TCI pump and effect site target concentration of 0.8ng/ml and 0.2 ng incremental target if needed.the goals of infusion are analgesia during nasal manipulation,sufficient respiratory rate(>8/min),and acceptable consciousness (OAA/S equal or more than 3).
Interventions/Control_2	In group B: remifentanil loading dose of 0.75 mic/kg body weight over 30 s, followed by a continous infusion 0.075 mic/kg/min.The goals are the same as group A.
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	18 years-old <=
Age-upper limit	56 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA class I-III patients who need nasotracheal intubation for elective maxillofacial surgery and have documented or suspected cervical spinal injurey in which any neck movement is considered a risk.
Key exclusion criteria	history of drug abuse, long term use of sedatives such as benzodiazepines, uncontrolled hypertensive disease.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Middle name Last name Dr. naser yeganeh
Organization	kermanshah university of medical sciences
Division name	anesthesiology and intensive care department
Zip code
Address	kermanshah university,kermanshah,Iran
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	kermanshah university of medical sciences
Division name	anesthesiology and intensive care department
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	deputy of research and technology of kermanshah university of medical sciences.
Institute
Department

Funding Source
Organization	deputy of research and technology of kermanshah university of medical sciences.
Organization
Division
Category of Funding Organization	Outside Japan
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	2008 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

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	2008 Year 12 Month 30 Day
Date of IRB
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2008 Year 12 Month 01 Day
Date of closure to data entry	2009 Year 04 Month 01 Day
Date trial data considered complete	2009 Year 05 Month 01 Day
Date analysis concluded	2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2008 Year 12 Month 18 Day
Last modified on	2009 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001905

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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