The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

Study Overview
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Brief Summary
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The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral cancer patients undergoing general anesthesia will provide adequate sedation and analgesia without respiratory depression and upper airway obstruction.

Detailed Description
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Case number: 60, ASA I-III oral cancer patients with limited mouth opening Patients will be randomly allocated into three groups, Dex group received dexmedetomidine (1.0 mcg/kg) infusion, Control group received saline, and Propofol group received 1% Propofol administrated usng effect-site TCI. Main outcome was evaluated by grading scores presenting conditions for nasal intubation, post-intubation and satisfaction. Other analysed parameters included airway obstruction, hemodynamic changes, treatment for hemodynamics response, consumption time for intubation, amnesia level, and postoperative adverse events. All outcome measurements were classified by scoring systems.

Official Title
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Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation

Conditions
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Awake Fiberoptic Nasal Intubation

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: Normal Saline 0.9%
* Drug: propofol 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and neck cancer patients with limited mouth opening Undergoing awake fiberoptic nasal intubation for elective surgery Exclusion Criteria: a history of severe bradycardia any type of A-V block in EKG heart failure liver cirrhosis thrombocytopenia coagulopathy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 dex group<br>received dexmedetomidine (1.0 mcg/kg) infusion | Drug: dexmedetomidine<br>* dexmedetomidine 1.0 mcg/kg infusion for 10minutes<br>* Other names: Precedex 100microg/ml;|
| Placebo Comparator: 2 control group<br>received 0.9% saline | Drug: Normal Saline 0.9%<br>* 0.9% Normal Saline 0.25ml/kg infusion for 10minues<br>* Other names: saline 0.9% Nacl;|
| Active Comparator: 3 Propofol group<br>received 1% propofol using effect-site TCI(Base Primea, Fresenius, France) | Drug: propofol 1%<br>* Propofol: The initial target = 3 μg/ml. The TCI is adjusted by 0.5μg/ml according to patient comfort during the procedure. The Orchestra® Base Primea(Fresenius, Brezins, France) offers a Target Controlled Infusion (TCI) target controlled infusion.<br>* Other names: propofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grading scores presenting conditions for nasal intubation |  | before and after intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Fiberoptic nasal intubation, satisfaction