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

NCT06581731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-23

No results posted yet for this study

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

Interventions

DRUG

remimazolam combined with remifentanil

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.

DRUG

dexmedetomidine combined with remifentanil

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.

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Hongwei Shi · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2025-09-10
Completion
2025-10-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06581731 on ClinicalTrials.gov