The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Awake Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dezocine

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

Group Type EXPERIMENTAL

Docozine

Intervention Type DRUG

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

Controlled

The same amount of saline is given for 10 seconds after surface anesthesia

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

The same amount of saline is given for 10 seconds after surface anesthesia

Interventions

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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

Intervention Type DRUG

Saline

The same amount of saline is given for 10 seconds after surface anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent；
2. Selective surgery and general anesthesia patients；
3. Age 18-65 yrs；
4. Anesthesia Society of American (ASA) Scale I\~II；

Exclusion Criteria

1. Mallampatis Ⅲ-Ⅳ；
2. Heat rate \< 50 beats/minutes；
3. II-III Atrioventricular block；
4. Use of alpha agonist or antagonist within two weeks；
5. Use of opioid within 24 hours；
6. Serious heart, liver, kidney disease and cerebrovascular disease；
7. Allergic to the trial drug and other anesthesia drug contraindication；
8. Factors existed that affect language communication；
9. Any respiratory disease；
10. Unsuccessful intubation for 3 times or drop out during intubation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No