Awake Tracheal Intubation
Conditions
Keywords
docozine
Brief 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.
Interventions
DRUGDocozine
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
DRUGSaline
The same amount of saline is given for 10 seconds after surface anesthesia
Sponsors
The First Affiliated Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of cough response | anesthesia induction | The cough scale is used to assess cough response the during anesthesia induction |
| The variation of heart rate | anesthesia induction | The variation of heart rate(bpm）during anesthesia induction |
| The variation of pulse oxygen saturation | anesthesia induction | The variation of pulse oxygen saturation(%) during anesthesia induction |
| Sedation assessment | anesthesia induction | Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction |
| The variation of blood pressure | anesthesia induction | The variation of blood pressure（mmHg) during anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of treatment-related adverse events | from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery | The incidence of treatment-related adverse events as assessed by CTCAE v4.0 |
| The occurrence of cardiovascular events | from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery | 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 |
Countries
China
Outcome results
None listed