Nausea and Vomiting Clinical Trial
Official title:
A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study of Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting
Verified date | July 2023 |
Source | Sichuan Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | December 30, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. For patients with an estimated duration of anesthesia =1h and =3h (non-emergency, non-cardiothoracic surgery and non-intracranial surgery), laparoscopic surgery, gastrointestinal surgery, obstetrics and gynecology surgery, tympanoplasty, tonstonectomy, etc., are preferred. The duration of hand anesthesia was defined as the period from the beginning of anesthesia induction to the end of anesthesia maintenance 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. |
Country | Name | City | State |
---|---|---|---|
China | Sichuan Provincial People's Hospital | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Mengchang Yang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | The average number of rescues within 24 and 48 hours after surgery in each group | Severe vomiting (level 3 or above) requires rescue treatment | Day 2 |
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