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This study uses cyclopropofol as a positive control and adopts a large sample, multicenter, randomized, single-blind, positive parallel control test design to explore the clinical application value of cyclopropofol in preventing postoperative nausea and vomiting.
Before the end of the anesthesia maintenance period/operation, it was divided into groups A, B and C according to different drug regimens. The subjects were randomly assigned to one of them in a 1:1:1 ratio to receive cyclopophenol or sevoflurane anesthesia. Each group of subjects should be roughly consistent according to the proportion of each number of PO . After screening the object, the researchers of each testing center are confirmed by the researchers of the center, log in to the random system, fill in the screening information, obtain the random number information, and distribute the corresponding research drugs according to the random number. The number of random shelters is generated through SAS software, which is used as a centralized random grouping system to import the total number of drugs. This study sets up evaluation researchers and drug management researchers. The whole experimental process turned a blind eye to not only the subjects, but also the evaluators. This study has set up evaluation investigators and administrative investigators. Administrative researchers are only involved in the random grouping, dispensing and delivery process. Other processes, including the subject's informed consent, screening, efficacy indicators and safety evaluation, and planned visits, are completed by the evaluation investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group cyclophenol | Active Comparator | Calculated by body weight (kg), the initial dose of continuous infusion of cyclopophenol is 0.8 mg/kg/h. During the infusion, the researchers adjusted the rate according to the reaction of the subjects, and the adjustment range was 0.4 mg/kg/h-2.4 mg/kg/h. |
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| group heptaflurane | Active Comparator | The anesthetic sevoflurane is inhaled for anesthesia maintenance. The initial concentration of sevoflurane is 1.5-2.0%, which can be adjusted to the expected effect according to the subject's reaction. |
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| group heptaflurane combined cyclophenol | Experimental | Inhaled anesthetic sevoflurane combined with a small dose of cyclopophenol for anesthesia maintenance. The initial concentration of sevoflurane is 0.5%, and the initial dose of cyclopophenol is 0.4 mg/kg/h.After that, sevoflurane or cyclopophenol (with an adjustment range of 0.2 mg/kg/h-1.2 mg/kg/h) can be adjusted to the expected effect according to the subject's reaction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heptaflurane combined Cyclophenol | Drug | Heptaflurane combined Cyclophenol |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of PONV within 24 hours after each group's operation. | PONV incidence (%) = (number of patients with nausea and vomiting / number of PONV incidence (%) = (number of patients with nausea and vomiting / number of people in the group) × 100% | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of nausea and vomiting within 48 hours after surgery in each group | PONV incidence (%) = (number of patients with nausea and vomiting / number of PONV incidence (%) = (number of patients with nausea and vomiting / number of people in the group) × 100% | Day 2 |
| The average number of rescues within 24 and 48 hours after surgery in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Sichuan | China |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Heptaflurane | Drug | Heptaflurane only |
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| Cyclophenol | Drug | Cyclophenol only |
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Severe vomiting (level 3 or above) requires rescue treatment |
| Day 2 |