COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Prevention of Nausea and Vomiting in Patients After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02021851
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Information provided by (Responsible Party):
Sevgi Bilgen, Yeditepe University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Dexamethasone and aprepitant Drug: Dexamethasone and ondansetron Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Complete response [ Time Frame: One year ]
    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.

Secondary Outcome Measures :
  1. Nausea [ Time Frame: One year ]
    The secondary outcome measure is incidence of nausea

  2. Retching [ Time Frame: One year ]
    The secondary outcome measure is incidence of retching

  3. Vomiting [ Time Frame: One year ]
    The secondary outcome measure is incidence of vomiting

  4. Need of rescue antiemetic [ Time Frame: One year ]
    The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.

Other Outcome Measures:
  1. Opioid consumption [ Time Frame: One year ]
    Opioid consumption

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02021851

Layout table for location information
Yeditepe University Hospital
Devlet Yolu, Ankara cad 102/104, Kozyatagi ISTANBUL, Turkey, 34752
Sponsors and Collaborators
Yeditepe University Hospital
Layout table for additonal information
Responsible Party: Sevgi Bilgen, Assistant professor, Yeditepe University Hospital Identifier: NCT02021851    
Other Study ID Numbers: 125
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Sevgi Bilgen, Yeditepe University Hospital:
Laparoscopic surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents