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Completed

NCT Number: NCT02021851

Prevention of Nausea and Vomiting in Patients After Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yeditepe University Hospital

Devlet Yolu, Ankara Cad 102/104, Kozyatagi Istanbul, 34752, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dexamethasone and aprepitant

Drug

Dexamethasone and Ondansetron

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  1. Opioid consumption

    Time frame: One year

    Opioid consumption

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 27, 2013
Registry last updated
Dec 27, 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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