Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265507
• Other study ID #: Glycopyrronium and ondansetron
• Status: Recruiting
• Phase: Phase 4
• Start date: March 21, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: March 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Guangyou Duan, MD
• Phone: (+86)18323376014
• Email: duangy[@]hospital.cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Glycopyrronium
Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
• Ondansetron
Glycopyrronium (4mg) was intravenously given at the ending of the surgery.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (23)

Lead Sponsor

Collaborator

The Second Affiliated Hospital of Chongqing Medical University

ChongGang General Hospital, CHONGQING BANAN HOSPITAL OF TCM, Chongqing Liangping District People's Hospital, Chongqing Medical Center for Women and Children, Chongqing Medical University, Chongqing Public Health Medical Center, Chongqing University Jiangjin Hospital, Chongqing Yongchuan District People's Hospital, Dianjiang People's Hospital of Chongqing, Jiulongpo People's Hospital of chongqing, People's Hospital of Pengshui County, The First People's Hospital Of Chongqing Liang Jiang New Area, The Ninth People's Hospital of Chongqing, The People's Hospital of DAZU ,Chongqing, The People's Hospital of Nanchuan, The People's Hospital of Qijiang District,Chongqing, The People's Hospital of Tongliang District, Chongqing city, The People's Hospital of Yubei District of Chongqing city, University-Town Hospital of Chongqing Medical University, West China Hospital, Xiangya Hospital of Central South University, Yunyang people's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative pain intensity	Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)	from the ending of surgery to 24 hours after surgery
Other	Postoperative analgesic requirements	Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump	from the ending of surgery to 24 hours after surgery
Other	degree of satisfaction	degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)	from the ending of surgery to 24 hours after surgery
Other	adverse reaction related to glycopyrronium and ondansetron	adverse reaction is recorded according to follow-up visits after surgery	from the ending of surgery to 24 hours after surgery
Primary	incidence of postoperative nausea and vomiting	postoperative nausea and vomiting is recorded according to follow-up visits after surgery	from the ending of surgery to 24 hours after surgery
Secondary	intensity of postoperative nausea	intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)	from the ending of surgery to 24 hours after surgery
Secondary	incidence of postoperative vomiting	postoperative vomiting is recorded according to follow-up visits after surgery	from the ending of surgery to 24 hours after surgery
Secondary	incidence of intervention requirement for nausea and vomiting	this event is recorded according to follow-up visits after surgery	from the ending of surgery to 24 hours after surgery