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

CSPC Pharmaceutical Group

Status and phase: Not yet enrolling; Phase 3

Conditions: Post-operative Nausea and Vomiting (PONV)

Treatments: Drug: Aprepitant Injection; Drug: Aprepitant Injection Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06543966

SYH9053-002

Details and patient eligibility

About

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).,

Full 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).

Enrollment: 486 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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486 participants in 2 patient groups, including a placebo group

Aprepitant Injection

Experimental group

Description:

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

Treatment:

Drug: Aprepitant Injection

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Aprepitant Injection Placebo