NCT04753515

Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation

Comparison Between Dexmedetomidine and Propofol for Sedation When Combined With Midazolam and Remifentanil During Awake Endotracheal Intubation: A Randomized Double-blind Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the sedation effect of dexmedetomidine and propofol when they are both combined with midazolam and remifentanil during awake endotracheal intubation.

Detailed description

Awake intubation is one of the best strategy guaranteed by the American Society of Anesthesiologists (ASA) guidelines for the management of patients with anticipated difficult airways. Hemodynamic stability, optimal intubating conditions, patients' comfort, amnesia and preservation of patents' spontaneous respiration are critical for awake intubation. Sedation is one of the key elements for this technique. Intravenous midazolam, propofol, dexmedetomidine and remifentanil are commonly used as sedatives during awake intubation. These agents are not preferred to be used alone but in combination with each other for the purpose of minimizing their respective side effects. The aim of this randomized controlled trial is to compare the safety and effectiveness of dexmedetomidine versus propofol for sedation during awake endotracheal intubation when they are both combined with midazolam and remifentanil.

Conditions

• Sedation
• Intubation

Interventions

Type	Name	Description
DRUG	dexmedetomidine combined with midazolam and remifentanil.	Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.5 mcg/kg dexmedetomidine over 5 min via separate syringe pumps.
DRUG	propofol combined with midazolam and remifentanil.	Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.33 mg/kg propoful over 5 min via separate syringe pumps.

Timeline

• Start date: 2021-03-05
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2021-02-15
• Last updated: 2022-11-30

Locations

1 site across 1 country: China