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

• Status: Enrolling by invitation
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study uses cyclopropofol as a positive control and adopts a large sample, multi-center, random, double-blind and positive parallel control test design to explore the clinical application value of cyclopropofol in preventing postoperative nausea and vomiting.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mengchang Yang

Criteria

Inclusion Criteria:

1. At least 2 of the 4 induced risk factors of PONV (risk factors are: history of PONV or motion sickness, habitual non-smoking, women, receiving opioid analgesia).

2. Selective surgery that requires tracheal intubation (non-emergency, non- cardiothoracic surgery and non-intracranial surgery, laparoscopic surgery, gastrointestinal surgery, obstetrics and gynecology surgery, tympanoplasty, tonsillectomy, etc. The operation time is expected to last at least 1 hour) The subjects need to be hospitalized overnight after surgery. The operation time is defined as from the beginning of the study of the drug to the completion of the last stitch.

3. Male or female, age ≥ 18 years old, ASA-PS score I to III.

Exclusion Criteria:

1. There is a history of vestibular nerve disorder or dizziness or nausea and vomiting 24 hours before the operation; or receiving conventional antiemetic treatment.

2. The subjects who need to maintain ventilation after surgery or need to place the nasogastric tube in place for a period of time.

3. The subject who the researcher believes that there are any other factors that are not suitable to participate in the research.