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The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

NCT02673723 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2019-02-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Principal Investigators

  • Wei Er Gu, PhD,MD · First affiliated Hospital of Anhui Medical University Locations: China,

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-08-31
Completion
2018-12-31

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 NCT02673723 on ClinicalTrials.gov