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

NCT05837156 | Unknown Phase 1

• 1 other identifier: 950429
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea and Vomiting

Keywords

Cyclophenol; Heptaflurane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The incidence of nausea and vomiting within 48 hours after surgery in each group

  Day 2

• The average number of rescues within 24 and 48 hours after surgery in each group

  Day 2

Study Arms (3)

group cyclophenol

ACTIVE COMPARATOR

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

group heptaflurane

ACTIVE COMPARATOR

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

group heptaflurane combined cyclophenol

EXPERIMENTAL

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

Interventions

Heptaflurane combined Cyclophenol DRUG

Heptaflurane combined Cyclophenol

group heptaflurane combined cyclophenol

Heptaflurane DRUG

Heptaflurane only

group heptaflurane

Cyclophenol DRUG

Cyclophenol only

group cyclophenol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• There is a history of vestibular nerve disorder or dizziness or nausea and vomiting 24 hours before the operation; or receiving conventional antiemetic treatment.
• The subjects who need to maintain ventilation after surgery or need to place the nasogastric tube in place for a period of time.
• The subject who the researcher believes that there are any other factors that are not suitable to participate in the research.

Sponsors & Collaborators

• Mengchang Yang: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Sichuan, China

Location

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 1, 2023
• Study Start: August 2, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)