Clinical trial NCT05331651: Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting
Official title: Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Chongqing General Hospital
name: Chongqing Medical University
name: The People's Hospital of DAZU ，Chongqing
name: The People's Hospital of Chongqing Kaizhou District
name: Fuling Hospital affiliated to Chongqing University
name: Qianjiang Central Hospital of Chongqing
name: Stomatological Hospital of Chongqing Medical University
name: People's Hospital of Changshou Chongqing
name: The Ninth People's Hospital of Chongqing
name: The First People's Hospital Of Chongqing Liang Jiang New Area
name: People's Hospital of Xiushan County
name: Wushan County People's Hospital
name: Three Gorges Hospital of Chongqing University
name: First Affiliated Hospital of Chongqing Medical University
name: Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University
name: The People's Hospital of Nanchuan
name: Chongqing Traditional Chinese Medicine Hospital
name: People's Hospital of Shapingba District， Chongqing
name: Chongqing Liangping District People's Hospital
name: Chongqing Jiangbei Hospital of Traditional Chinese Medicine
name: People's Hospital of Chongqing Hechuan
First posted: 2022-04-15
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 in combination with tropisetron and normal saline in combination with tropisetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium as adjuvant drug to prevent postoperative nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Non-cardiac surgery
* 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 tropisetron
* 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: Department of Anesthesiology, 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: