Clinical trial NCT05881486: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Anesthesia Complication
Thoracic Diseases
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of PONV within 24 hours
timeFrame: Day 1
Secondary outcomes:
measure: Incidence of PONV within 48 hours
timeFrame: Day 2
measure: occurrence of Drug-related adverse effects
timeFrame: Day 3
measure: Postoperative pain score
timeFrame: Day 3
measure: The dosage of opioids used after surgery
timeFrame: Day 3
measure: the length of hospital stay
timeFrame: From date of admission until the date of discharge, assessed up to 7 days.
measure: postoperative pulmonary complications
timeFrame: Day 3
Other outcomes:
Locations:
Study officials:
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