UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001586 |
|---|---|
| Receipt number | R000001905 |
| 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 |
| Date of disclosure of the study information | 2008/12/30 |
| Last modified on | 2009/12/25 03:20:30 |
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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
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
Sponsor or person
Institute
deputy of research and technology of kermanshah university of medical sciences.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001905
