Postoperative Nausea and Vomiting, Anesthesia Complication, Thoracic Diseases
Conditions
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.
Interventions
DRUGOndansetron 8mg
8 mg Ondansetron+100 ml normal saline
150 mg fosaprepitant +100 ml normal saline
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| The dosage of opioids used after surgery | Day 3 | This project will be measured by the dosage of opioid drugs used after surgery. |
Contacts
Primary ContactJinying Zhang
Outcome results
None listed