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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Glycopyrronium in Combination With Tropisetron; Drug: Normal Saline in Combination With Tropisetron

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glycopyrronium in Combination With Tropisetron	Drug: Glycopyrronium in Combination With Tropisetron; Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.
Placebo Comparator: Normal Saline in Combination With Tropisetron	Drug: Normal Saline in Combination With Tropisetron; Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Serotonin 5-HT3 Receptor Antagonists; Glycopyrrolate; Tropisetron
• Other Study ID Numbers: Glycopyrronium in anti-PONV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Time Frame: Within five years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No