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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dezocine | Experimental | 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 | Placebo Comparator | The same amount of saline is given for 10 seconds after surface anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docozine | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Er Gu, PhD,MD | First affiliated Hospital of Anhui Medical University Locations: China, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing Municipal Hospital | Anqing | Anhui | 231402 | China | ||
| Chaohu Affiliated Hospital of Anhui Medical University |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | The same amount of saline is given for 10 seconds after surface anesthesia |
|
| 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 |
| Chaohu |
| Anhui |
| 238000 |
| China |
| Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| The second People's Hospital of Wuhu | Wuhu | Anhui | 241000 | China |
| D017670 |
| Sodium Compounds |