Difficult or Failed IntubationNCT06581731
Comparison of Remifentanil With a Combination of Remimazolam and Dexmedetomidine for Awake Tracheal Intubation
A study testing remimazolam combined with remifentanil and dexmedetomidine combined with remifentanil in people with Difficult or Failed Intubation and Sedative Adverse Reaction, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Awake fiberoptic intubation (AFOI) requires airway surface anesthesia to inhibit pharyngeal reflex, glottis closure reflex, and cough reflex. Additionally, the use of sedative drugs can enhance patient comfort and tolerance, reduce anxiety, and eliminate harmful effects on systemic hemodynamics.The objective of this… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Difficult or Failed Intubation, Sedative Adverse Reaction
- What is being tested?
- remimazolam combined with remifentanil and dexmedetomidine combined with remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2024to 4 Mar 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective open cervical spine surgery.
- Age 18-65 years old
- ASA classifications of I-III
- BMI<30kg/m2
Who cannot join
- Patients allergic to propofol, midazolam, dexmedetomidine, remifentanil.
- Second- or third-degree atrioventricular block, rate <50 beats/min, systolic blood pressure <90 mmHg
- Acute exacerbation of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD)
- Patients with acute arrhythmias and severe heart disease (congenital, valvular diseases)
- Patients with severe liver or kidney dysfunction requiring replacement therapy
- Patients with severe mental disorders requiring medication for symptom control and experiencing communication barriers
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- Patients with moderate to severe anemia, coagulation disorders, and hematologic diseases
- Patients with basal skull fractures, facial fractures, significantly deviated nasal septum, or nasal cavity diseases causing severe nasal congestion
- patients on long-term opioids or sedative medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Safety and Effectiveness of Remifentanil With a Combination of Remimazolam and Dexmedetomidine for Awake Fibreoptic Nasotracheal Intubation
Awake fiberoptic intubation (AFOI) requires airway surface anesthesia to inhibit pharyngeal reflex, glottis closure reflex, and cough reflex. Additionally, the use of sedative drugs can enhance patient comfort and tolerance, reduce anxiety, and eliminate harmful effects on systemic hemodynamics.The objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation.
Read the detailed description
Awake fiberoptic intubation (AFOI) is regarded as the gold standard for managing anticipated difficult airways due to its high success rate and low risk. However, awake intubation can induce significant stress responses in patients, including increased heart rate, severe blood pressure fluctuations, and intense coughing. Therefore, during awake intubation, airway local anesthesia techniques are necessary to suppress the gag reflex, glottic closure reflex, and cough reflex, enabling the patient to tolerate the stress responses associated with intubation. In addition to local anesthesia, sedatives are typically required to enhance patient comfort and tolerance, reduce anxiety, and minimize adverse effects on systemic hemodynamics. However, excessive sedation can lead to complications such as airway collapse, hypoxemia, and respiratory depression, while insufficient sedation may result in severe coughing and discomfort. The ideal sedative state preserves spontaneous breathing, maintains low sensitivity to nausea and vomiting, and allows for awakening if necessary. Safety and comfort are the primary considerations in selecting sedative medications; therefore, sedative and analgesic drugs used in AFOI should be short-acting, easily titratable, and minimally suppressive of spontaneous respiration.The most commonly used sedatives include benzodiazepines, propofol, remifentanil, and dexmedetomidine. During AFOI, a combination of the two drugs can be used to meet the requirements of sedation and analgesia. Remifentanil has a fast onset, fast elimination, and does not rely on liver and kidney function. It is the first ultra short acting opioid drug in clinical practice, and its termination of action is not significantly related to infusion time and dose. It provides sufficient analgesia and good anesthesia controllability for patients with difficult airway during conscious intubation. Rimazolen is an ester metabolite derivative of the benzodiazepine drug midazolam, which has been successfully used for the induction and maintenance of programmed sedation and general anesthesia due to its fast onset, short duration of sedative effect, and short recovery time, with a half-life of 5-10 minutes. In addition, remifentanil has no effect on heart rate, electrocardiogram, blood pressure, and respiratory rate. Rimazolen accumulates rarely after long-term infusion and does not affect liver and kidney function, making it safe for patients with liver or kidney dysfunction. In addition, remifentanil sedation can be reversed by flumazenil, and it may be a useful medication in clinical situations that require maintenance of spontaneous ventilation. Research reports that the combination of benzodiazepines and opioids may be an ideal drug for AFOI. Dexmedetomidine is a highly selective α 2-adrenergic agonist that produces dose-dependent sedative and anti anxiety effects, with a certain degree of analgesic effect. It can preserve airway reflex, dilate tracheal smooth muscle, and inhibit cough response without causing respiratory depression. However, it may cause bradycardia, heart block, and hypotension, and has a slow onset when used alone. Dexmedetomidine has a rapid onset of action and a terminal half-life of 2 hours. It is metabolized in the liver and its metabolites are eliminated through urine. Therefore, the dosage should be reduced appropriately in patients with renal or liver dysfunction. Dexmedetomidine combined with opioid drugs is also commonly used for AFOI.
There is currently no consensus on the safest and most effective sedative drugs for conscious tracheal intubation, and using a single drug often fails to meet all the requirements of Awake Fiberoptic Intubation (AFOI). The ideal sedative should provide effective conscious sedation while maintaining autonomous ventilation, ensuring smooth intubation conditions, and stabilizing hemodynamics. Therefore, the objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation.
- Being tested
- remimazolam combined with remifentanil, dexmedetomidine combined with remifentanil
- Keywords
- AFOI, Dexmedetomidine, Rimazazolam, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam combined with remifentanilDrug
Also called remimazolam-remifentanil
Patients in this group will receive remimazolam as a loading dose of 0.05 mg·kg-¹, followed by continuous infusion at 0.5mg·kg-¹·h-¹and a dose of 0.1 μg/kg/min remifentanilvia separate syringe pumps.
dexmedetomidine combined with remifentanilDrug
Also called dexmedetomidine-remifentanil
Patients in this group will receive a loading dose of dexmedetomidine 0.5μg/kg over 10 minutes intravenously, and then a dose of 0.1 μg/kg/min remifentanil and 0.5 μg/kg/h dexmedetomidine via separate syringe pumps.
| Study group | Role | What they receive |
|---|---|---|
| group remimazolam-remifentanil | Experimental | received remimazolam as a loading dose of 0.05 mg·kg-¹, followed by continuous infusion at 0.5mg·kg-¹·h-¹ Receives: Drug: remimazolam combined with remifentanil; Drug: dexmedetomidine combined with remifentanil |
| group dexmedetomidine-remifentanil | Experimental | eceived dexmedetomidine as a loading dose of 0.5 μg·kg-¹ over 10 minutes, followed by continuous infusion at 0.5 μg·kg-¹·h-¹. Receives: Drug: remimazolam combined with remifentanil; Drug: dexmedetomidine combined with remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal cord mobility
1 = fully patent, 2 = partial mobility, 3 = partial closure, 4 = complete closure
Measured: preoperative
Cough response
1 = absent, 2 = mild, 3 = moderate, 4 = severe
Measured: preoperative
extremity movement
1 = none, 2 = mild, 3 = moderate, 4 = severe
Measured: preoperative
Secondary outcomes (8)
hypoxia
SPO2<90%
Measured: intraoperative
occurrence of adverse reactions other than hypoxia
hypertension, hypotension, tachycardia, bradycardia
Measured: intraoperative
clinical outcome immediately following the Awake Fiberoptic Intubation
1, cooperative; 2, restless with minimal resistance; 3, severe resistance with immediate application of general anesthesia
Measured: intraoperative
recall of the Awake Fiberoptic Intubation
1 = none, 2 = partial, and 3 = full
Measured: postoperative 24 hours
satisfaction score of the Awake Fiberoptic Intubation
1 = excellent, 2 = good, 3 = acceptable, and 4 = poor
Measured: postoperative 24 hours
Airway patency
1 = fully patent, 2 = obstruction relieved by neck extension, 3 = obstruction requiring jaw retraction
Measured: intraoperative
intubation comfort scores
1 = no reaction; 2 = slight grimacing; 3 = severe grimacing; 4 = verbal objection; and 5 = defensive movement of the head, hands, or feet)
Measured: intraoperative
side effects
sore throat and nasal bleeding
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start14 Jun 2024
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult or Failed IntubationStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwei Shi, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581731
- Sponsor's protocol ID
- KY20240514-01
- Status last verified
- May 2024
- First submitted
- 30 Aug 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Safety and Effectiveness of Remifentanil With a Combination of Remimazolam and Dexmedetomidine for Awake Fibreoptic Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT06581731
- Acronym / sponsor ID
- KY20240514-01
- Keywords
- AFOI, Dexmedetomidine, Rimazazolam, Remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 3 Sep 2024 (actual)
- 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.
Awake fiberoptic intubation (AFOI) requires airway surface anesthesia to inhibit pharyngeal reflex, glottis closure reflex, and cough reflex. Additionally, the use of sedative drugs can enhance patient comfort and tolerance, reduce anxiety, and eliminate harmful effects on systemic hemodynamics.The objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation.
Detailed description
Awake fiberoptic intubation (AFOI) is regarded as the gold standard for managing anticipated difficult airways due to its high success rate and low risk. However, awake intubation can induce significant stress responses in patients, including increased heart rate, severe blood pressure fluctuations, and intense coughing. Therefore, during awake intubation, airway local anesthesia techniques are necessary to suppress the gag reflex, glottic closure reflex, and cough reflex, enabling the patient to tolerate the stress responses associated with intubation. In addition to local anesthesia, sedatives are typically required to enhance patient comfort and tolerance, reduce anxiety, and minimize adverse effects on systemic hemodynamics. However, excessive sedation can lead to complications such as airway collapse, hypoxemia, and respiratory depression, while insufficient sedation may result in severe coughing and discomfort. The ideal sedative state preserves spontaneous breathing, maintains low sensitivity to nausea and vomiting, and allows for awakening if necessary. Safety and comfort are the primary considerations in selecting sedative medications; therefore, sedative and analgesic drugs used in AFOI should be short-acting, easily titratable, and minimally suppressive of spontaneous respiration.The most commonly used sedatives include benzodiazepines, propofol, remifentanil, and dexmedetomidine. During AFOI, a combination of the two drugs can be used to meet the requirements of sedation and analgesia. Remifentanil has a fast onset, fast elimination, and does not rely on liver and kidney function. It is the first ultra short acting opioid drug in clinical practice, and its termination of action is not significantly related to infusion time and dose. It provides sufficient analgesia and good anesthesia controllability for patients with difficult airway during conscious intubation. Rimazolen is an ester metabolite derivative of the benzodiazepine drug midazolam, which has been successfully used for the induction and maintenance of programmed sedation and general anesthesia due to its fast onset, short duration of sedative effect, and short recovery time, with a half-life of 5-10 minutes. In addition, remifentanil has no effect on heart rate, electrocardiogram, blood pressure, and respiratory rate. Rimazolen accumulates rarely after long-term infusion and does not affect liver and kidney function, making it safe for patients with liver or kidney dysfunction. In addition, remifentanil sedation can be reversed by flumazenil, and it may be a useful medication in clinical situations that require maintenance of spontaneous ventilation. Research reports that the combination of benzodiazepines and opioids may be an ideal drug for AFOI. Dexmedetomidine is a highly selective α 2-adrenergic agonist that produces dose-dependent sedative and anti anxiety effects, with a certain degree of analgesic effect. It can preserve airway reflex, dilate tracheal smooth muscle, and inhibit cough response without causing respiratory depression. However, it may cause bradycardia, heart block, and hypotension, and has a slow onset when used alone. Dexmedetomidine has a rapid onset of action and a terminal half-life of 2 hours. It is metabolized in the liver and its metabolites are eliminated through urine. Therefore, the dosage should be reduced appropriately in patients with renal or liver dysfunction. Dexmedetomidine combined with opioid drugs is also commonly used for AFOI.
There is currently no consensus on the safest and most effective sedative drugs for conscious tracheal intubation, and using a single drug often fails to meet all the requirements of Awake Fiberoptic Intubation (AFOI). The ideal sedative should provide effective conscious sedation while maintaining autonomous ventilation, ensuring smooth intubation conditions, and stabilizing hemodynamics. Therefore, the objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group remimazolam-remifentanil | Experimental | Drug: remimazolam combined with remifentanil, Drug: dexmedetomidine combined with remifentanilreceived remimazolam as a loading dose of 0.05 mg·kg-¹, followed by continuous infusion at 0.5mg·kg-¹·h-¹ |
| group dexmedetomidine-remifentanil | Experimental | Drug: remimazolam combined with remifentanil, Drug: dexmedetomidine combined with remifentanileceived dexmedetomidine as a loading dose of 0.5 μg·kg-¹ over 10 minutes, followed by continuous infusion at 0.5 μg·kg-¹·h-¹. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective open cervical spine surgery.
- Age 18-65 years old
- ASA classifications of I-III
- BMI<30kg/m2
Key exclusion criteria (9 listed)
- Patients allergic to propofol, midazolam, dexmedetomidine, remifentanil.
- Second- or third-degree atrioventricular block, rate <50 beats/min, systolic blood pressure <90 mmHg
- Acute exacerbation of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD)
- Patients with acute arrhythmias and severe heart disease (congenital, valvular diseases)
- Patients with severe liver or kidney dysfunction requiring replacement therapy
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 |
|---|---|---|
| remimazolam combined with remifentanilAlso: remimazolam-remifentanilPatients in this group will receive remimazolam as a loading dose of 0.05 mg·kg-¹, followed by continuous infusion at 0.5mg·kg-¹·h-¹and a dose of 0.1 μg/kg/min remifentanilvia separate syringe pumps. | Drug | group dexmedetomidine-remifentanil, group remimazolam-remifentanil |
| dexmedetomidine combined with remifentanilAlso: dexmedetomidine-remifentanilPatients in this group will receive a loading dose of dexmedetomidine 0.5μg/kg over 10 minutes intravenously, and then a dose of 0.1 μg/kg/min remifentanil and 0.5 μg/kg/h dexmedetomidine via separate syringe pumps. | Drug | group dexmedetomidine-remifentanil, group remimazolam-remifentanil |
Primary outcome
Vocal cord mobility
Time frame: preoperative
1 = fully patent, 2 = partial mobility, 3 = partial closure, 4 = complete closure
Cough response
Time frame: preoperative
1 = absent, 2 = mild, 3 = moderate, 4 = severe
extremity movement
Time frame: preoperative
1 = none, 2 = mild, 3 = moderate, 4 = severe
8 secondary outcomes
hypoxia
Time frame: intraoperative
occurrence of adverse reactions other than hypoxia
Time frame: intraoperative
clinical outcome immediately following the Awake Fiberoptic Intubation
Time frame: intraoperative
recall of the Awake Fiberoptic Intubation
Time frame: postoperative 24 hours
satisfaction score of the Awake Fiberoptic Intubation
Time frame: postoperative 24 hours
Airway patency
Time frame: intraoperative
intubation comfort scores
Time frame: intraoperative
side effects
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
Hongwei Shi study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam combined with remifentanil and dexmedetomidine combined with remifentanil in people with Difficult or Failed Intubation and Sedative Adverse Reaction, run by Nanjing First Hospital, Nanjing Medical University at 1 site 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 4 inclusion and 9 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 13 Jul 2026. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vocal cord mobility (time frame: preoperative). The study lists 3 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 13 Jul 2026.