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Not yet recruiting NCT06543966

Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

Phase III Interventional Post-operative Nausea and Vomiting (PONV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aprepitant Injection, Aprepitant Injection Placebo.
Who it may be relevant to
Registry conditions: Post-operative Nausea and Vomiting (PONV). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting

Overview

A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,

Detailed description

In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).

Interventions

  • Drug Aprepitant Injection
    Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
  • Drug Aprepitant Injection Placebo
    Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds

Primary outcome measures

  • Complete response (CR) rates over 24 hours after the end of surgery [Time frame: 0-24 hours after the end of surgery]
Secondary outcome measures (7)
  • Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery [Time frame: 0-24 hours after the end of surgery]
  • Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery [Time frame: 0-24 hours after the end of surgery]
  • Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery [Time frame: 0-24 hours after the end of surgery]
  • Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery [Time frame: 0-24 hours after the end of surgery]
  • Time to treatment failure in the 0 to 24 hours following the end of surgery [Time frame: 0-24 hours after the end of surgery]
  • Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery [Time frame: 0-48 hours after the end of surgery]
  • The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery [Time frame: 0-48 hours after the end of surgery]

Eligibility criteria

Inclusion criteria

Age ≥18 and ≤75 years old; 18 < BMI≤30kg/m\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.

expected or agreed to stay in the hospital for 24 hours or more after surgery;

Exclusion criteria

diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06543966 · SYH9053-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗