Status:
COMPLETED
Remimazolam and Postoperative Nausea and Vomiting in High-risk Patients
Lead Sponsor:
Peking University First Hospital
Conditions:
Postoperative Nausea and Vomiting
Benzodiazepine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial aims to explore whether the intraoperative use of remimazolam can reduce the incidence of postoperative nausea and vomiting (PONV) in high-risk patients. According to the Apfel's simplified...
Detailed Description
Postoperative nausea and vomiting (PONV) is a common adverse event after general anesthesia. The incidence of PONV within 2 hours after surgery was approximately 14% in patients undergoing laparoscopi...
Eligibility Criteria
Inclusion
- Age ≥18 years old;
- Scheduled to undergo elective surgery under general anesthesia;
- Judged to be at high risk of postoperative nausea and vomiting. According to the Apfel's simplified score, patients with 3 or more of the following factors are at high-risk: women, non-smokers, history of PONV, postoperative use of opioids.
Exclusion
- Refuse to participate;
- Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
- Severe liver dysfunction (Child-Pugh class C);
- Severe renal dysfunction (dialysis required);
- Patients of the American Society of Anesthesiologists (ASA) grade 4 and above;
- Emergency surgery;
- Continuously taking benzodiazepines for more than 1 week before surgery;
- Any other circumstances that are considered unsuitable for study participation by attending physicians or investigators.
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2023
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT04861337
Start Date
May 19 2021
End Date
April 22 2023
Last Update
January 3 2024
Active Locations (10)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Beijing Hospital of the Ministry of Health
Beijing, Beijing Municipality, China
3
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
4
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China