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Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

Primary Purpose

Postoperative Nausea and Vomiting, Anesthesia Complication, Thoracic Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ondansetron 8mg
Fosaprepitant 150 mg
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aged between 18 and 70 years physical status classified by the American Society of Anesthesiologists (ASA) scale as I to III Apfel score ≥ 2 undergoing thoracoscopic pneumonectomy Exclusion Criteria: Preoperative disorders of consciousness body mass index (BMI) > 35 kg/m2 occurrence of episodes of nausea or vomiting within 24 h prior to surgery、motion sickness,、previous PONV、people who smoke、people with alcoholism、use of corticosteroids, psychoactive or antiemetic drugs,、hypersensitivity to the study medications serious kidney, liver, lung, heart, brain or bone marrow disease conversion from thoracoscopic pneumonectomy to conventional pneumonectomy participation in another clinical study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fosaprepitant

    Ondansetron

    Arm Description

    Participants undergoing thoracoscopic pneumonectomy will receive 150 mg of fosaprepitant and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.

    Participants undergoing thoracoscopic pneumonectomy received 8 mg of ondansetron and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.

    Outcomes

    Primary Outcome Measures

    Incidence of PONV within 24 hours
    The groups will be analyzed and compared for frequency of nausea and vomiting in 24 h after surgery

    Secondary Outcome Measures

    Incidence of PONV within 48 hours
    The groups will be analyzed and compared for frequency of nausea and vomiting in 48 h after surgery
    occurrence of Drug-related adverse effects
    The groups will be compared for the incidence of unwanted effects of antiemetic medicines include onstipation,weakness, headache, dizziness and sleepiness.
    Postoperative pain score
    This project will be measured by patients' postoperative pain score.
    The dosage of opioids used after surgery
    This project will be measured by the dosage of opioid drugs used after surgery.
    the length of hospital stay
    The groups will be compared for the time from admission to discharge
    postoperative pulmonary complications
    Postoperative pulmonary complications include respiratory infection,respiratory failure,pleural effusion,atelectasis and pneumothorax

    Full Information

    First Posted
    May 3, 2023
    Last Updated
    June 4, 2023
    Sponsor
    Qilu Hospital of Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05881486
    Brief Title
    Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery
    Official Title
    The Effects of Intravenous Fosaprepitant and Ondansetron for the Prevention of Postoperative Nausea and Vomiting in Thoracicsurgery Patients: A Single-center, Randomized, Double-Blinded Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qilu Hospital of Shandong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare the efficacy, safety and feasibility of intravenous Fosaprepitant and Ondansetron for the prevention of postoperative nausea and vomiting in thoracicsurgery patients. Participants will be randomized in a 1:1 ratio to the Fosaprepitant and Ondansetron group.The groups were analyzed and compared for frequency of vomiting in 24 h after surgery. In addition, we will further compare the occurrence of postoperative pulmonary complications, length of hospital stay, nutrition and quality of life after surgery in patients treated with different antiemetic prophylaxis.
    Detailed Description
    Postoperative nausea and vomiting (PONV) is a common postoperative complication of general anesthesia. The antiemetic 5-serotonin 3 (5-HT 3) receptor antagonist is widely used in postoperative anti-emesis,However, more clinical studies are needed to confirm whether neurokinin-1 (NK-1) receptor antagonists have better effects on PONV than 5-HT 3 receptor antagonists.We aimed to evaluate the effects of NK-1 receptor antagonists and 5-HT 3 receptor antagonists on PONV through a randomized controlled study. To this end, we took patients undergoing thoracic surgery as the research object, they received an antiemetic prophylaxis with ondansetron or fosaprepitant, and the frequency of postoperative nausea and vomiting the of the two antiemetic prophylaxis regimens were analyzed, and the occurrence of pulmonary complications, length of hospital stay, the nutrition and quality of life after surgery administration were also compared. Through this clinical trial, we hope to obtain a better antiemetic prophylaxis regimen and provide clear information for patients and physicians to guide clinical decisions that enhance treatment efficacy and reduce the occurrence of side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting, Anesthesia Complication, Thoracic Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    234 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fosaprepitant
    Arm Type
    Experimental
    Arm Description
    Participants undergoing thoracoscopic pneumonectomy will receive 150 mg of fosaprepitant and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
    Arm Title
    Ondansetron
    Arm Type
    Active Comparator
    Arm Description
    Participants undergoing thoracoscopic pneumonectomy received 8 mg of ondansetron and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    Ondansetron 8mg
    Intervention Description
    8 mg Ondansetron+100 ml normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    Fosaprepitant 150 mg
    Intervention Description
    150 mg fosaprepitant +100 ml normal saline
    Primary Outcome Measure Information:
    Title
    Incidence of PONV within 24 hours
    Description
    The groups will be analyzed and compared for frequency of nausea and vomiting in 24 h after surgery
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Incidence of PONV within 48 hours
    Description
    The groups will be analyzed and compared for frequency of nausea and vomiting in 48 h after surgery
    Time Frame
    Day 2
    Title
    occurrence of Drug-related adverse effects
    Description
    The groups will be compared for the incidence of unwanted effects of antiemetic medicines include onstipation,weakness, headache, dizziness and sleepiness.
    Time Frame
    Day 3
    Title
    Postoperative pain score
    Description
    This project will be measured by patients' postoperative pain score.
    Time Frame
    Day 3
    Title
    The dosage of opioids used after surgery
    Description
    This project will be measured by the dosage of opioid drugs used after surgery.
    Time Frame
    Day 3
    Title
    the length of hospital stay
    Description
    The groups will be compared for the time from admission to discharge
    Time Frame
    From date of admission until the date of discharge, assessed up to 7 days.
    Title
    postoperative pulmonary complications
    Description
    Postoperative pulmonary complications include respiratory infection,respiratory failure,pleural effusion,atelectasis and pneumothorax
    Time Frame
    Day 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged between 18 and 70 years physical status classified by the American Society of Anesthesiologists (ASA) scale as I to III Apfel score ≥ 2 undergoing thoracoscopic pneumonectomy Exclusion Criteria: Preoperative disorders of consciousness body mass index (BMI) > 35 kg/m2 occurrence of episodes of nausea or vomiting within 24 h prior to surgery、motion sickness,、previous PONV、people who smoke、people with alcoholism、use of corticosteroids, psychoactive or antiemetic drugs,、hypersensitivity to the study medications serious kidney, liver, lung, heart, brain or bone marrow disease conversion from thoracoscopic pneumonectomy to conventional pneumonectomy participation in another clinical study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinying Zhang
    Phone
    18560087707
    Email
    zhjydzx@163.com

    12. IPD Sharing Statement

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    Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

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