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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01474213 |
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Date of registration:
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31/10/2011 |
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Primary sponsor: |
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Public title:
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Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
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Scientific title:
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Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01474213 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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China
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Contacts
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Name:
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Hong Jiang, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA grade I-III adult patients with difficult airway, who were undergoing elective
oral maxillofacial surgery
Exclusion Criteria:
- pregnant or lactating female,
- long-term opioids or sedative medication,
- patients < 18 years of age,
- severe bradycardia (HR < 50 beats/min),
- hypotension (systolic pressure < 90mmHg),
- any type of atrioventricular block on the ECG
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intubation; Difficult
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Intervention(s)
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Drug: dexmedetomidine group
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Drug: remifentanil group
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Primary Outcome(s)
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Patient's reaction to procedure
[Time Frame: the duration of intubation, an expected average of 10 minutes]
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Secondary Outcome(s)
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Cardiac rhythm
[Time Frame: 15 minutes before intubation and duration of intubation]
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continuous ECG
[Time Frame: 15 minutes before intubation and duration of intubation]
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End tidal carbon dioxide
[Time Frame: 15 minutes before intubation and duration of intubation]
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HR
[Time Frame: 15 minutes before intubation and duration of intubation]
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NIBP
[Time Frame: 15 minutes before intubation, duration of intubation]
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Oxygen Saturation
[Time Frame: 15 minutes before intubation and duration of intubation]
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post operative visit
[Time Frame: 24 hours]
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RR
[Time Frame: 15 minutes before intubation and duration of intubation]
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Secondary ID(s)
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JYMZK-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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