NCT02673723

The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled，Double Blinded Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: The First Affiliated Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia. Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of awake tracheal intubation, however, the outstanding problem is serious respiratory depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced cough during general anesthesia induction.It is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dezocine prevents sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe and effective method for awake tracheal intubation.

Conditions

• Awake Tracheal Intubation

Interventions

Type	Name	Description
DRUG	Docozine	dezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia
DRUG	Saline	The same amount of saline is given for 10 seconds after surface anesthesia

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-08-01
• Completion: 2018-12-01
• First posted: 2016-02-04
• Last updated: 2019-02-15

Locations

4 sites across 1 country: China