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

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05837156
• Other study ID #: 950429
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: August 2, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Heptaflurane combined Cyclophenol
Heptaflurane combined Cyclophenol
• Heptaflurane
Heptaflurane only
• Cyclophenol
Cyclophenol only

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Mengchang Yang

Country where clinical trial is conducted

China, 

Outcome

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