NCT05837156

A Clinical Study to Evaluate Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting

A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study of Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Mengchang Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Heptaflurane combined Cyclophenol	Heptaflurane combined Cyclophenol
DRUG	Heptaflurane	Heptaflurane only
DRUG	Cyclophenol	Cyclophenol only

Timeline

• Start date: 2023-08-02
• Primary completion: 2023-10-01
• Completion: 2023-12-30
• First posted: 2023-05-01
• Last updated: 2023-07-27

Locations

1 site across 1 country: China