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

NCT05265507 | Unknown Phase 4 DMC

• 1 other identifier: Glycopyrronium and ondansetron
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• intensity of postoperative nausea

  from the ending of surgery to 24 hours after surgery

• incidence of postoperative vomiting

  from the ending of surgery to 24 hours after surgery

• incidence of intervention requirement for nausea and vomiting

  from the ending of surgery to 24 hours after surgery

Other Outcomes (4)

• Postoperative pain intensity

  from the ending of surgery to 24 hours after surgery

• Postoperative analgesic requirements

  from the ending of surgery to 24 hours after surgery

• degree of satisfaction

  from the ending of surgery to 24 hours after surgery

Study Arms (2)

Glycopyrronium

EXPERIMENTAL

Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.

Drug: Glycopyrronium

Ondansetron

ACTIVE COMPARATOR

Ondansetron (4mg) was intravenously given at the ending of the surgery.

Drug: Ondansetron

Interventions

Glycopyrronium DRUG

Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.

Glycopyrronium

Ondansetron DRUG

Glycopyrronium (4mg) was intravenously given at the ending of the surgery.

Ondansetron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Glycopyrrolate; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• He Huang, MD

  The Second Affiliated Hospital, Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangyou Duan, MD

CONTACT

(+86)18323376014; duangy@hospital.cqmu.edu.cn

Dagang Wang, MD

CONTACT

+86 023 63693014; kuanrenlunli@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 3, 2022
• Study Start: March 21, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 24, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within five years

Locations

CN (1)