Comparison of Remifentanil with a Combination of Remimazolam and Dexmedetomidine for Awake Tracheal Intubation

NCT06581731 | Recruiting DMC

• 1 other identifier: KY20240514-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation.

Conditions

Difficult or Failed Intubation; Sedative Adverse Reaction

Keywords

AFOI; Dexmedetomidine; Rimazazolam; Remifentanil

Outcome Measures

Primary Outcomes (2)

• intubation scores

  Perform a four-level scoring based on vocal cord movement (open, movement, closed), cough intensity (none, mild, moderate, severe), and limb movement (none, mild, moderate, severe).

  preoperative

• intubation comfort scores

  patient tolerance was assessed by intubation comfort scores (1, no reaction, no change or a single change in the facial expression; 2, slight reaction, grimacing facial expressions; 3, moderate reaction, severe facial grimace but retained ability to follow verbal command and no reflex head movements; 4 severe reaction, severe facial grimace associated with head movements, but patient remains able to obey verbal commands; 5, very severe reaction, severe facial grimace associated with protective head and limb movements hindering the procedure and an inability to obey any verbal command; 6, uncooperative)

  preoperative

Secondary Outcomes (5)

• hypoxia

  intraoperative

• occurrence of adverse reactions other than hypoxia

  intraoperative

• clinical outcome immediately following the Awake Fiberoptic Intubation

  intraoperative

• recall of the Awake Fiberoptic Intubation

  after surgery, up to 24h

• satisfaction score of the Awake Fiberoptic Intubation

  after surgery, up to 24h

Study Arms (2)

group remimazolam-remifentanil

EXPERIMENTAL

Administer 5 mg of remimazolam intravenously, followed by a continuous infusion at a rate of 0.5 mg/kg/h to maintain anesthesia.

Drug: remimazolam combined with remifentanil; Drug: dexmedetomidine combined with remifentanil

group dexmedetomidine-remifentanil

EXPERIMENTAL

Administer 1 μg/kg of dexmedetomidine as an intravenous bolus over 10 minutes, followed by a continuous infusion at 0.5 μg/kg/h to maintain anesthesia.

Drug: remimazolam combined with remifentanil; Drug: dexmedetomidine combined with remifentanil

Interventions

remimazolam combined with remifentanil DRUG

Patients in this group will receive a bolus of remimazolam 5 mg intravenously, and then a dose of 0.1 μg/kg/min remifentanil and 0.5 mg/kg/h remimazolam via separate syringe pumps.

Also known as: remimazolam-remifentanil

group dexmedetomidine-remifentanil; group remimazolam-remifentanil

dexmedetomidine combined with remifentanil DRUG

Patients in this group will receive a loading dose of dexmedetomidine 1 μg/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.

Also known as: dexmedetomidine-remifentanil

group dexmedetomidine-remifentanil; group remimazolam-remifentanil

Eligibility Criteria

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

You may qualify if:

• Patients undergoing general anesthesia who require awake nasal tracheal intubation.
• Age 18-65 years old
• ASA classifications of I-III
• BMI\<30kg/m2

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hongwei Shi

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jing Hu, MD

CONTACT

15366110201; hujingmz@@163.com

Lihai Chen

CONTACT

13951807033; chenlihai1983@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: September 19, 2024
• Primary Completion: September 10, 2025
• Study Completion: October 20, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-05

Locations

CN (1)