Intubation; DifficultPhase 4NCT01474213
Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
A Phase 4 study testing dexmedetomidine group and remifentanil group in people with Intubation; Difficult, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
Trial summary
The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- dexmedetomidine group and remifentanil group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2011to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery
Who cannot join
- pregnant or lactating female,
- long-term opioids or sedative medication,
- patients < 18 years of age,
- severe bradycardia (HR < 50 beats/min),
- hypotension (systolic pressure < 90mmHg),
- any type of atrioventricular block on the ECG
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai Municipality, 200011
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation
The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.
Read the detailed description
Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.
- Conditions
- Intubation; Difficult
- Being tested
- dexmedetomidine group, remifentanil group
- Keywords
- dexmedetomidine, remifentanil, awake nasotracheal fibreoptic intubation, oral maxillofacial surgery, difficult airway, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine groupDrug
Also called Dexmedetomidine Hydrochloride Injection
1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine
remifentanil groupDrug
Also called Remifentanil
target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h Receives: Drug: dexmedetomidine group |
| remifentanil | Active comparator | The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived. Receives: Drug: remifentanil group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy Scores
Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.
Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing
Measured: during the procedure of fibreoptic and tracheal intubation
Intubation Score
graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing
Measured: during the inserting of the tracheal tube
Secondary outcomes (7)
Patient's Reaction to Procedure
Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.
Clinical score Level of sedation
- Patient is anxious and agitated or restless, or both
- Patient is cooperative, oriented and tranquil
- Patient responds to commands only
- Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus
- Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
- Patient exhibits no response to stimuli
Measured: the duration of intubation, an expected average of 10 minutes
Post Operative Visit
visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.
Measured: 24 hours
Mean Arterial Blood Pressure
MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Measured: 15 minutes before intubation, endoscopy point, intubation point
Heart Rate
Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Measured: 15 minutes before intubation, endoscopy point, intubation point
Peripheral Oxygen Saturation(SPO2)
Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Measured: 15 minutes before intubation, endoscopy point, intubation point
Cardiac Rhythm
Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.
Measured: 15 minutes before intubation and duration of intubation
Post Intubation Score
Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.
Post-intubation score 1 2 3
- Cooperative, obeying commands
- Uncomfortable, GA imminent
- Other（specify）
Measured: immediately after the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Hu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Hong Jiang, MD, PHD, Study chair, Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474213
- Sponsor's protocol ID
- JYMZK-002
- Status last verified
- Oct 2012
- First submitted
- 31 Oct 2011
- Last updated
- 21 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT01474213
- Acronym / sponsor ID
- JYMZK-002
- Conditions
- Intubation; Difficult
- Keywords
- dexmedetomidine, remifentanil, awake nasotracheal fibreoptic intubation, oral maxillofacial surgery, difficult airway, adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Posted 21 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.
Detailed description
Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: dexmedetomidine groupa loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h |
| remifentanil | Active comparator | Drug: remifentanil groupThe initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery
Key exclusion criteria (6 listed)
- pregnant or lactating female,
- long-term opioids or sedative medication,
- patients < 18 years of age,
- severe bradycardia (HR < 50 beats/min),
- hypotension (systolic pressure < 90mmHg),
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 |
|---|---|---|
| dexmedetomidine groupAlso: Dexmedetomidine Hydrochloride Injection1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine | Drug | dexmedetomidine |
| remifentanil groupAlso: Remifentaniltarget controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration) | Drug | remifentanil |
Primary outcome
Endoscopy Scores
Time frame: during the procedure of fibreoptic and tracheal intubation
Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition. Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing
Intubation Score
Time frame: during the inserting of the tracheal tube
graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing
7 secondary outcomes
Patient's Reaction to Procedure
Time frame: the duration of intubation, an expected average of 10 minutes
Post Operative Visit
Time frame: 24 hours
Mean Arterial Blood Pressure
Time frame: 15 minutes before intubation, endoscopy point, intubation point
Heart Rate
Time frame: 15 minutes before intubation, endoscopy point, intubation point
Peripheral Oxygen Saturation(SPO2)
Time frame: 15 minutes before intubation, endoscopy point, intubation point
Cardiac Rhythm
Time frame: 15 minutes before intubation and duration of intubation
Post Intubation Score
Time frame: immediately after the intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hong Jiang, MD, PHD study chair
Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine group and remifentanil group in people with Intubation; Difficult, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
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 1 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: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopy Scores (time frame: during the procedure of fibreoptic and tracheal intubation). The study lists 2 primary outcomes in all. 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 21 Nov 2012.