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| ID | Type | Description | Link |
|---|---|---|---|
| 2009L01628 | Other Identifier | State Food and Drug Administration of P.R. China |
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In this trial, our primary goal is to investigate the safety of intravenous infusion of emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop severe adverse event in any dose group or any volunteer develop fatal adverse event in any group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (0.0024 ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg. |
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| Arm 2 (0.006ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.006ml/kg. |
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| Arm 3 (0.012ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.012ml/kg. |
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| Arm 4 (0.02ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.02ml/kg. |
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| Arm 5 (0.0301ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0301ml/kg. |
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| Arm 6 (0.0391ml/kg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emulsified Isoflurane | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs | The vital signs include heart rate, cardiac rhythm, blood pressure, respiratory rate, pulse oxygen saturation, body temperature and end-tidal carbon dioxide. All the parameters are measured at the following time points:
| after drug infusion to 24 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of emulsified isoflurane as an intravenous anesthetics | This secondary outcome is an observational one only. The response to verbal command, to pain stimulus; and eyelash reflex are tested. The orientation and finger-to-nose test are also tested. The end-tidal partial pressure of isoflurane, observer's assessment of alertness/sedation (modified OAS/S score) and Bispectral index (BIS) are also recored. |
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Inclusion Criteria:
Age 18~45 years old (50:50 male:female) healthy volunteer;
Body Mass Index (BMI) 19~24;
health volunteers assessed by medical history and physical examination
Non-smoker and no history of alcohol or drug abuse;
Fully understand the whole process of this trial and sign the informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Liu, M.D | Department of Anesthesiology, West China Hospital, Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Drug Clinical Trial• GCP Center,West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0391ml/kg. |
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| Arm 7 (0.0508ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0508ml/kg. |
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| Arm 8 (0.066ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.066ml/kg. |
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| Arm 9 (0.0859ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0859ml/kg. |
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| Arm 10 (0.1116ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1116ml/kg. |
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| Arm 11 (0.1451ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1451ml/kg. |
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| Arm 12 (0.1886ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1886ml/kg. |
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| Arm 13 (0.2452ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.2452ml/kg. |
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| Arm 14 (0.3188ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.3188ml/kg. |
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| Arm 15 (0.4144ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.4144ml/kg. |
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| Arm 16 (0.5387ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.5387ml/kg. |
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| immediate from drug infusion, up to 24 hours after infusion |