The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

NCT ID: NCT00815893

Last Updated: 2009-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-08-31

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.

Conditions

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Awake Fiberoptic Nasal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 dex group

received dexmedetomidine (1.0 mcg/kg) infusion

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

dexmedetomidine 1.0 mcg/kg infusion for 10minutes

2 control group

received 0.9% saline

Group Type PLACEBO_COMPARATOR

Normal Saline 0.9%

Intervention Type DRUG

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

3 Propofol group

received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)

Group Type ACTIVE_COMPARATOR

propofol 1%

Intervention Type 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.

Interventions

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dexmedetomidine

dexmedetomidine 1.0 mcg/kg infusion for 10minutes

Intervention Type DRUG

Normal Saline 0.9%

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

Intervention Type DRUG

propofol 1%

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.

Intervention Type DRUG

Other Intervention Names

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Precedex 100microg/ml saline 0.9% Nacl propofol

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital

Principal Investigators

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Koung-Shing Chu, Master

Role: STUDY_DIRECTOR

Kaohsiung Medical University

Locations

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Kaohsiung Medical University Chung-Ho Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Koung-Shing Chu, Master

Role: CONTACT

886-7-3121101 ext. 7035

Cheng-Jing Tsai

Role: CONTACT

886-7-3121131 ext. 7033

Facility Contacts

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Koung-Shing Chu, Master

Role: primary

886-7-3121101 ext. 7035

Other Identifiers

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KMUHIRB-96-09-02

Identifier Type: -

Identifier Source: org_study_id

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