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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 dex group | Experimental | received dexmedetomidine (1.0 mcg/kg) infusion |
|
| 2 control group | Placebo Comparator | received 0.9% saline |
|
| 3 Propofol group | Active Comparator | received 1% propofol using effect-site TCI(Base Primea, Fresenius, France) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | dexmedetomidine 1.0 mcg/kg infusion for 10minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| grading scores presenting conditions for nasal intubation | before and after intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koung-Shing Chu, Master | Contact | 886-7-3121101 | 7035 | cks0708@ms.kmuh.org.tw |
| Cheng-Jing Tsai | Contact | 886-7-3121131 | 7033 | t8501107@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Koung-Shing Chu, Master | Kaohsiung Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal Saline 0.9% | Drug | 0.9% Normal Saline 0.25ml/kg infusion for 10minues |
|
|
| propofol 1% | Drug | 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. |
|
|
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |