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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2026-03-28

Brief Summary

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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).,

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Detailed Description

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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).

Conditions

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Post-operative Nausea and Vomiting (PONV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parrallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aprepitant Injection

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Group Type EXPERIMENTAL

Aprepitant Injection

Intervention Type DRUG

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Placebo

Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds

Group Type PLACEBO_COMPARATOR

Aprepitant Injection Placebo

Intervention Type DRUG

Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds

Interventions

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Aprepitant Injection

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Intervention Type DRUG

Aprepitant Injection Placebo

Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No