Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

NCT05881486 | Unknown

• 1 other identifier: KYLL-202210-072-1
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting; Anesthesia Complication; Thoracic Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of PONV within 24 hours

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

  Day 1

Secondary Outcomes (6)

• Incidence of PONV within 48 hours

  Day 2

• occurrence of Drug-related adverse effects

  Day 3

• Postoperative pain score

  Day 3

• The dosage of opioids used after surgery

  Day 3

• the length of hospital stay

  From date of admission until the date of discharge, assessed up to 7 days.

Study Arms (2)

Fosaprepitant

EXPERIMENTAL

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

Drug: Fosaprepitant 150 mg

Ondansetron

ACTIVE COMPARATOR

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

Drug: Ondansetron 8mg

Interventions

Ondansetron 8mg DRUG

8 mg Ondansetron+100 ml normal saline

Ondansetron

Fosaprepitant 150 mg DRUG

150 mg fosaprepitant +100 ml normal saline

Fosaprepitant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Related Publications (17)

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  PMID: 33075160 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Thoracic Diseases

Interventions

Ondansetron; fosaprepitant

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Jinying Zhang

CONTACT

18560087707; zhjydzx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-01