Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05331651
• Other study ID #: Glycopyrronium in anti-PONV
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Glycopyrronium in Combination With Tropisetron
Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.
• Normal Saline in Combination With Tropisetron
Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Locations

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

Sponsors (22)

Lead Sponsor

Collaborator

The Second Affiliated Hospital of Chongqing Medical University

Chongqing General Hospital, Chongqing Jiangbei Hospital of Traditional Chinese Medicine, Chongqing Liangping District People's Hospital, Chongqing Medical University, Chongqing Traditional Chinese Medicine Hospital, Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University, First Affiliated Hospital of Chongqing Medical University, Fuling Hospital affiliated to Chongqing University, People's Hospital of Changshou Chongqing, People's Hospital of Chongqing Hechuan, People's Hospital of Shapingba District, Chongqing, People's Hospital of Xiushan County, Qianjiang Central Hospital of Chongqing, Stomatological Hospital of Chongqing Medical University, The First People's Hospital Of Chongqing Liang Jiang New Area, The Ninth People's Hospital of Chongqing, The People's Hospital of Chongqing Kaizhou District, The People's Hospital of DAZU ,Chongqing, The People's Hospital of Nanchuan, Three Gorges Hospital of Chongqing University, Wushan County 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