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

NCT01897337 | Completed Phase 4

• 1 other identifier: 3-2012-0076
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• incidence and severity of postoperative nausea and vomiting

  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.

  upto 2 days after surgery

Secondary Outcomes (2)

• adverse event

  upto 2 days after surgery

• pain

  upto 2 days after surgery

Study Arms (2)

Aprepitant group

EXPERIMENTAL

We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room)

Drug: Aprepitant

placebo group

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

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.

Also known as: Emend

Aprepitant group

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.

placebo group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Gangnam severance hospital

Seoul, South Korea

Location

Related Publications (1)

• Ham SY, Shim YH, Kim EH, Son MJ, Park WS, Lee JS. Aprepitant for antiemesis after laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):90-5. doi: 10.1097/EJA.0000000000000242.

  PMID: 26694939 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yon Hee Shim

  Yonsei University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

KR (1)