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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nausea and Vomiting
• Intervention / Treatment: Drug: Cyclophenol; Drug: Heptaflurane; Drug: Heptaflurane combined Cyclophenol

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan, China
    • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group cyclophenol; 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.	Drug: Cyclophenol; Cyclophenol only
Active Comparator: group heptaflurane; 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.	Drug: Heptaflurane; Heptaflurane only
Experimental: group heptaflurane combined cyclophenol; 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.	Drug: Heptaflurane combined Cyclophenol; Heptaflurane combined Cyclophenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Severe vomiting (level 3 or above) requires rescue treatment	Day 2

Collaborators and Investigators

• Sponsor: Mengchang Yang

Study record dates

Study Major Dates

• Study Start (Estimated): August 2, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cyclophenol; Heptaflurane
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 950429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No