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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001586 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | traumatic injured patients who need nasotracheal intubation for elective maxillofacial surgery and have documented or suspected cervical spinal injurey | |
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
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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 |
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Name of lead principal investigator |
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Organization | kermanshah university of medical sciences | ||||||
Division name | anesthesiology and intensive care department | ||||||
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Address | kermanshah university,kermanshah,Iran | ||||||
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Organization | kermanshah university of medical sciences | ||||||
Division name | anesthesiology and intensive care department | ||||||
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Sponsor | |
Institute | deputy of research and technology of kermanshah university of medical sciences. |
Institute | |
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Funding Source | |
Organization | deputy of research and technology of kermanshah university of medical sciences. |
Organization | |
Division | |
Category of Funding Organization | Outside Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |