Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

Not Applicable

Not yet recruiting

• Conditions: Postoperative Nausea and Vomiting; Thoracic Diseases; Anesthesia Complication
• Interventions: Drug: Fosaprepitant 150 mg; Drug: Ondansetron 8mg

• Registration Number: NCT05881486
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-31
• Study Start: 2023-06
• Primary Completion: 2023-06
• Study Completion: 2023-06
• Last Update Submitted: 2023-06-04
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1. aged between 18 and 70 years
2. physical status classified by the American Society of Anesthesiologists (ASA) scale as I to III
3. Apfel score ≥ 2
4. undergoing thoracoscopic pneumonectomy

Exclusion Criteria

1. Preoperative disorders of consciousness
2. body mass index (BMI) > 35 kg/m2
3. 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
4. serious kidney, liver, lung, heart, brain or bone marrow disease
5. conversion from thoracoscopic pneumonectomy to conventional pneumonectomy
6. participation in another clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fosaprepitant	Fosaprepitant 150 mg	Participants undergoing thoracoscopic pneumonectomy will receive 150 mg of fosaprepitant and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
Ondansetron	Ondansetron 8mg	Participants undergoing thoracoscopic pneumonectomy received 8 mg of ondansetron and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of PONV within 24 hours	Day 1	The groups will be analyzed and compared for frequency of nausea and vomiting in 24 h after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of PONV within 48 hours	Day 2	The groups will be analyzed and compared for frequency of nausea and vomiting in 48 h after surgery
the length of hospital stay	From date of admission until the date of discharge, assessed up to 7 days.	The groups will be compared for the time from admission to discharge
postoperative pulmonary complications	Day 3	Postoperative pulmonary complications include respiratory infection,respiratory failure,pleural effusion,atelectasis and pneumothorax
Postoperative pain score	Day 3	This project will be measured by patients' postoperative pain score.
The dosage of opioids used after surgery	Day 3	This project will be measured by the dosage of opioid drugs used after surgery.
occurrence of Drug-related adverse effects	Day 3	The groups will be compared for the incidence of unwanted effects of antiemetic medicines include onstipation,weakness, headache, dizziness and sleepiness.