Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05881486

Collaborator

(none)

234

Enrollment

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting Anesthesia Complication Thoracic Diseases	Drug: Ondansetron 8mg Drug: Fosaprepitant 150 mg	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fosaprepitant 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 150 mg fosaprepitant +100 ml normal saline
Active Comparator: Ondansetron 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 8 mg Ondansetron+100 ml normal saline

Arm

Intervention/Treatment

Experimental: Fosaprepitant

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

150 mg fosaprepitant +100 ml normal saline

Active Comparator: Ondansetron

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

8 mg Ondansetron+100 ml normal saline

Outcome Measures

Primary Outcome Measures

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

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
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.
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.