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CompletedNCT02021851Updated Dec 27, 2013

Prevention of Nausea and Vomiting in Patients After Surgery

A Phase 4 interventional study of Dexamethasone and aprepitant and Dexamethasone and ondansetron in Postoperative Nausea and Vomiting, sponsored by Yeditepe University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-12-27.

Sponsored by Yeditepe University Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.

Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.

PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P\<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.

02

Conditions studied

  • Postoperative Nausea and Vomiting

Keywords

  • Dexamethasone,
  • Ondansetron
  • Aprepitant
  • PONV
  • Laparoscopic surgery
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In context

Postoperative Nausea and Vomiting

629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.

This study's enrollment of 67 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Yeditepe University Hospital is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 Years to 60 Years
  • ASA (American Society of Anesthesiologist) physical status I or II
  • Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity or contraindication to the study medications,
  • Antiemetic drug or steroid use within 24 hours before anesthesia,
  • History of diabetes mellitus,
  • History of motion sickness or postoperative nausea and vomiting,
  • Pregnancy,
  • Breast feeding
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Active comparator
    Group DA: Dexamethasone and aprepitant

    Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)

    Drug: Dexamethasone and aprepitant

  • Placebo comparator
    Group DO: Dexamethasone and ondansetron

    Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)

    Drug: Dexamethasone and ondansetron

Interventions

06

What researchers measure

Primary outcomes

  1. Complete response

    The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.

    Time frame: One year

Secondary outcomes

  1. Nausea

    The secondary outcome measure is incidence of nausea

    Time frame: One year

  2. Retching

    The secondary outcome measure is incidence of retching

    Time frame: One year

  3. Vomiting

    The secondary outcome measure is incidence of vomiting

    Time frame: One year

  4. Need of rescue antiemetic

    The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.

    Time frame: One year

Other outcomes

  1. Opioid consumption

    Opioid consumption

    Time frame: One year

07

Study locations

1 site
  • Yeditepe University Hospital
    Devlet Yolu, Ankara Cad 102/104, Kozyatagi Istanbul 34752, Turkey (Türkiye)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02021851
Lead sponsor
Yeditepe University Hospital
Responsible party
Sevgi Bilgen (Assistant professor, Yeditepe University Hospital) — Principal investigator
First posted
Dec 27, 2013
Start date
Jul 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Dec 27, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Dexamethasone · Aprepitant

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