Clinical trial NCT05265507: Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron
Official title: Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Chongqing University Jiangjin Hospital
name: Chongqing Medical University
name: The People's Hospital of DAZU ，Chongqing
name: Xiangya Hospital of Central South University
name: West China Hospital
name: The People's Hospital of Tongliang District， Chongqing city
name: Chongqing Medical Center for Women and Children
name: Dianjiang People's Hospital of Chongqing
name: The Ninth People's Hospital of Chongqing
name: The People's Hospital of Yubei District of Chongqing city
name: Chongqing Yongchuan District People's Hospital
name: The First People's Hospital Of Chongqing Liang Jiang New Area
name: ChongGang General Hospital
name: The People's Hospital of Nanchuan
name: People's Hospital of Pengshui County
name: Yunyang people's Hospital
name: Chongqing Liangping District People's Hospital
name: Jiulongpo People's Hospital of chongqing
name: The People's Hospital of Qijiang District，Chongqing
name: University-Town Hospital of Chongqing Medical University
name: Chongqing Public Health Medical Center
name: CHONGQING BANAN HOSPITAL OF TCM
First posted: 2022-03-03
Enrollment: 480
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: To compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification I-III
* Receive general anesthesia
* Voluntarily receive postoperative intravenous controlled analgesia

Exclusion Criteria:

* Puerpera or lactation women
* Allergy or existing contraindication to glycopyrronium and ondansetron
* Participate in other clinical drug trials within three months
* Can not follow with the study procedure

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: from the ending of surgery to 24 hours after surgery
Secondary outcomes:
measure: intensity of postoperative nausea
timeFrame: from the ending of surgery to 24 hours after surgery
measure: incidence of postoperative vomiting
timeFrame: from the ending of surgery to 24 hours after surgery
measure: incidence of intervention requirement for nausea and vomiting
timeFrame: from the ending of surgery to 24 hours after surgery
Other outcomes:
measure: Postoperative pain intensity
timeFrame: from the ending of surgery to 24 hours after surgery
measure: Postoperative analgesic requirements
timeFrame: from the ending of surgery to 24 hours after surgery
measure: degree of satisfaction
timeFrame: from the ending of surgery to 24 hours after surgery
measure: adverse reaction related to glycopyrronium and ondansetron
timeFrame: from the ending of surgery to 24 hours after surgery
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: