Safer sedation for awake intubation? trial tests drug combo
NCT ID NCT06581731
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This trial compares two sedation approaches for awake fiberoptic intubation, a procedure where a breathing tube is placed while the patient is conscious. One group receives remifentanil alone, while the other gets a combination of dexmedetomidine and remifentanil. The study measures how well the vocal cords open, coughing, and movement during the procedure, as well as side effects like low oxygen or blood pressure changes. Participants are adults aged 18-65 scheduled for elective cervical spine surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remifentanil, remimazolam, dexmedetomidine
- What this could lead to
- If one sedation method proves safer or more effective, it could become the preferred approach for awake intubation, reducing patient discomfort and complications.
- What could go wrong
- This is a small, early-stage trial with only 64 participants, so results may not apply to all patients. Both sedation methods carry risks like low oxygen or blood pressure changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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64 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients scheduled for elective open cervical spine surgery. 2. Age 18-65 years old 3. ASA classifications of I-III 4. BMI\<30kg/m2 Exclusion Criteria: 1. Patients allergic to propofol, midazolam, dexmedetomidine, remifentanil. 2. Second- or third-degree atrioventricular block, rate \<50 beats/min, systolic blood pressure \<90 mmHg 3. Acute exacerbation of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD) 4. Patients with acute arrhythmias and severe heart disease (congenital, valvular diseases) 5. Patients with severe liver or kidney dysfunction requiring replacement therapy 6. Patients with severe mental disorders requiring medication for symptom control and experiencing communication barriers 7. Patients with moderate to severe anemia, coagulation disorders, and hematologic diseases 8. Patients with basal skull fractures, facial fractures, significantly deviated nasal septum, or nasal cavity diseases causing severe nasal congestion 9. patients on long-term opioids or sedative medication
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, 210000, China
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