Status:
COMPLETED
Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
C.Surgical Procedure; Gastrointestinal
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PO...
Detailed Description
This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastroi...
Eligibility Criteria
Inclusion
- Age ≥18 years and Age ≤75 years;
- Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;
- The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.
Exclusion
- The American Society of Anesthesiologists (ASA) rating is \>3;
- Severe hepatic dysfunction(the score of Child-Pugh is \>9);
- With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ;
- Take medications with known antiemetic properties preoperatively ;
- With mental disorder, or not be able to communicate ;
- Pregnant women or nursing mothers.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2022
Estimated Enrollment :
1154 Patients enrolled
Trial Details
Trial ID
NCT04853147
Start Date
April 27 2021
End Date
October 12 2022
Last Update
December 29 2022
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655