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Prevention of Nausea and Vomiting in Patients After Surgery

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ClinicalTrials.gov Identifier: NCT02021851
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
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

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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
Official 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
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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02021851


Locations
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Turkey
Yeditepe University Hospital
Devlet Yolu, Ankara cad 102/104, Kozyatagi ISTANBUL, Turkey, 34752
Sponsors and Collaborators
Yeditepe University Hospital
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Responsible Party: Sevgi Bilgen, Assistant professor, Yeditepe University Hospital
ClinicalTrials.gov 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:
Dexamethasone,
Ondansetron
Aprepitant
PONV
Laparoscopic surgery
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Ondansetron
Aprepitant
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents