The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

The First Affiliated Hospital of Anhui Medical University

Status and phase: Completed; Phase 4

Conditions: Awake Tracheal Intubation

Treatments: Drug: Saline; Drug: Docozine

Study type: Interventional

Funder types: Other

Identifiers

NCT02673723

FirstHAnhuiMU

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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520 participants in 2 patient groups, including a placebo group

Dezocine

Experimental group

Description:

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

Treatment:

Drug: Docozine

Controlled

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline