The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

NCT00815893 | Unknown Phase 2 DMC

• 1 other identifier: KMUHIRB-96-09-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Awake Fiberoptic Nasal Intubation

Keywords

Dexmedetomidine; Fiberoptic nasal intubation; satisfaction

Outcome Measures

Primary Outcomes (1)

• grading scores presenting conditions for nasal intubation

  before and after intubation

Study Arms (3)

1 dex group

EXPERIMENTAL

received dexmedetomidine (1.0 mcg/kg) infusion

Drug: dexmedetomidine

2 control group

PLACEBO COMPARATOR

received 0.9% saline

Drug: Normal Saline 0.9%

3 Propofol group

ACTIVE COMPARATOR

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

Drug: propofol 1%

Interventions

dexmedetomidine DRUG

dexmedetomidine 1.0 mcg/kg infusion for 10minutes

Also known as: Precedex 100microg/ml

1 dex group

Normal Saline 0.9% DRUG

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

Also known as: saline 0.9% Nacl

2 control group

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.

Also known as: propofol

3 Propofol group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head and neck cancer patients with limited mouth opening
• Undergoing awake fiberoptic nasal intubation for elective surgery

You may not qualify if:

• a history of severe bradycardia
• any type of A-V block in EKG
• heart failure
• liver cirrhosis
• thrombocytopenia
• coagulopathy

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride; Propofol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Koung-Shing Chu, Master

  Kaohsiung Medical University

  STUDY DIRECTOR

Central Study Contacts

Koung-Shing Chu, Master

CONTACT

886-7-3121101; cks0708@ms.kmuh.org.tw

Cheng-Jing Tsai

CONTACT

886-7-3121131; t8501107@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 31, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 28, 2009

Record last verified: 2008-12

Locations

TW (1)