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The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00815893
Enrollment
60
Registered
2008-12-31
Start date
2008-08-31
Completion date
2009-08-31
Last updated
2009-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awake Fiberoptic Nasal Intubation

Keywords

Dexmedetomidine, Fiberoptic nasal intubation, satisfaction

Brief summary

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

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.

Interventions

DRUGdexmedetomidine

dexmedetomidine 1.0 mcg/kg infusion for 10minutes

DRUGNormal Saline 0.9%

0.9% Normal Saline 0.25ml/kg infusion for 10minues

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.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
grading scores presenting conditions for nasal intubationbefore and after intubation

Countries

Taiwan

Contacts

Primary ContactKoung-Shing Chu, Master
cks0708@ms.kmuh.org.tw886-7-3121101
Backup ContactCheng-Jing Tsai
t8501107@yahoo.com.tw886-7-3121131

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026