The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

Study Overview
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Brief Summary
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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.

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

Conditions
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Awake Tracheal Intubation

Intervention / Treatment
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* Drug: Docozine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent； Selective surgery and general anesthesia patients； Age 18-65 yrs； Anesthesia Society of American (ASA) Scale I II； Exclusion Criteria: Mallampatis Ⅲ-Ⅳ； Heat rate < 50 beats/minutes； II-III Atrioventricular block； Use of alpha agonist or antagonist within two weeks； Use of opioid within 24 hours； Serious heart, liver, kidney disease and cerebrovascular disease； Allergic to the trial drug and other anesthesia drug contraindication； Factors existed that affect language communication； Any respiratory disease； Unsuccessful intubation for 3 times or drop out during intubation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dezocine<br>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: Docozine<br>* 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<br>|
| Placebo Comparator: Controlled<br>The same amount of saline is given for 10 seconds after surface anesthesia | Drug: Saline<br>* The same amount of saline is given for 10 seconds after surface anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation assessment | Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction | anesthesia induction | 
| The occurrence of cough response | The cough scale is used to assess cough response the during anesthesia induction | anesthesia induction | 
| The variation of blood pressure | The variation of blood pressure（mmHg) during anesthesia induction | anesthesia induction | 
| The variation of heart rate | The variation of heart rate(bpm）during anesthesia induction | anesthesia induction | 
| The variation of pulse oxygen saturation | The variation of pulse oxygen saturation(%) during anesthesia induction | anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of cardiovascular events | The incidence of hypertension, hypotension, tachycardia and bradycardia from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery is recorded | from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery | 
| The occurrence of treatment-related adverse events | The incidence of treatment-related adverse events as assessed by CTCAE v4.0 | from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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docozine