Awake Fiberoptic Nasal IntubationPhase 2/3NCT00815893
The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
A Phase 2/3 study testing dexmedetomidine, Normal Saline 0.9% and propofol 1% in people with Awake Fiberoptic Nasal Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Awake Fiberoptic Nasal Intubation
- What is being tested?
- dexmedetomidine, Normal Saline 0.9% and propofol 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Aug 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck cancer patients with limited mouth opening
- Undergoing awake fiberoptic nasal intubation for elective surgery
Who cannot join
- a history of severe bradycardia
- any type of A-V block in EKG
- heart failure
- liver cirrhosis
- thrombocytopenia
- coagulopathy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung City, 807
Koung-Shing Chu, Master, 886-7-3121101 ext. 7035, cks0708@ms.kmuh.org.tw
About this study
Official title: Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation
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.
Read the 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.
- Conditions
- Awake Fiberoptic Nasal Intubation
- Being tested
- dexmedetomidine, Normal Saline 0.9%, propofol 1%
- Keywords
- Dexmedetomidine, Fiberoptic nasal intubation, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called Precedex 100microg/ml
dexmedetomidine 1.0 mcg/kg infusion for 10minutes
Normal Saline 0.9%Drug
Also called saline 0.9% Nacl
0.9% Normal Saline 0.25ml/kg infusion for 10minues
propofol 1%Drug
Also called propofol
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 dex group | Experimental | received dexmedetomidine (1.0 mcg/kg) infusion Receives: Drug: dexmedetomidine |
| 2 control group | Placebo comparator | received 0.9% saline Receives: Drug: Normal Saline 0.9% |
| 3 Propofol group | Active comparator | received 1% propofol using effect-site TCI(Base Primea, Fresenius, France) Receives: Drug: propofol 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
grading scores presenting conditions for nasal intubation
Measured: before and after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake Fiberoptic Nasal IntubationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Koung-Shing Chu, Master, Study director, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815893
- Sponsor's protocol ID
- KMUHIRB-96-09-02
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation
- ClinicalTrials.gov ID
- NCT00815893
- Acronym / sponsor ID
- KMUHIRB-96-09-02
- Conditions
- Awake Fiberoptic Nasal Intubation
- Keywords
- Dexmedetomidine, Fiberoptic nasal intubation, satisfaction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 dex group | Experimental | Drug: dexmedetomidinereceived dexmedetomidine (1.0 mcg/kg) infusion |
| 2 control group | Placebo comparator | Drug: Normal Saline 0.9%received 0.9% saline |
| 3 Propofol group | Active comparator | Drug: propofol 1%received 1% propofol using effect-site TCI(Base Primea, Fresenius, France) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Head and neck cancer patients with limited mouth opening
- Undergoing awake fiberoptic nasal intubation for elective surgery
Key exclusion criteria (6 listed)
- a history of severe bradycardia
- any type of A-V block in EKG
- heart failure
- liver cirrhosis
- thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineAlso: Precedex 100microg/mldexmedetomidine 1.0 mcg/kg infusion for 10minutes | Drug | 1 dex group |
| Normal Saline 0.9%Also: saline 0.9% Nacl0.9% Normal Saline 0.25ml/kg infusion for 10minues | Drug | 2 control group |
| propofol 1%Also: propofolPropofol: 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. | Drug | 3 Propofol group |
Primary outcome
grading scores presenting conditions for nasal intubation
Time frame: before and after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
Related trials for Awake Fiberoptic Nasal Intubation
Recruiting
Comparison of Awake Tracheal Intubation Methods
Airway Management Assessment, Awake Endotracheal Intubation
Not yet recruiting
A Nontraditional Approach for Awake Fiberoptic Nasotracheal Intubation.
Endotracheal Tube Placement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koung-Shing Chu, Master study director
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing dexmedetomidine, Normal Saline 0.9% and propofol 1% in people with Awake Fiberoptic Nasal Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Koung-Shing Chu, Master (886-7-3121101 ext. 7035, cks0708@ms.kmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grading scores presenting conditions for nasal intubation (time frame: before and after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2009.