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Completed

NCT Number: NCT01897337

The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting

PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.

So, we should prevent PONV in these patients by using multimodal or combination therapy.

Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.

In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing laparoscopic gynecologic surgery.
  • Patient who takes fentanyl based IV PCA
  • ASA class I-II

Exclusion criteria

  • allergy to aprepitant
  • take another antiemetics before surgery
  • decreased liver function
  • psychological disease
  • who cannot speak Korean
  • take medicines that interacts with emend who do not agree to the study

Treatment and study plan

Aprepitant

Drug

We administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.

Other names: Emend

Placebo

Drug

Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.

Primary outcomes

  1. incidence and severity of postoperative nausea and vomiting

    Time frame: upto 2 days after surgery

    Severity of PONV will be measured by using verbal numerical rating scale (0-10).

    Incidence of retching or vomiting will also be recorded upto 2 days after surgery.

Secondary outcomes

  1. adverse event

    Time frame: upto 2 days after surgery

    abdominal pain, headache, diziness, drowsiness, constipation, pruritus, etc

  2. pain

    Time frame: upto 2 days after surgery

    Pain is assessed with verbal numeric rating scale. (0-10)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2013
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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