Skip to main content
OpenTrials
Completed

NCT Number: NCT05331651

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glycopyrronium in Combination With Tropisetron

Drug

Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Normal Saline in Combination With Tropisetron

Drug

Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Primary outcomes

  1. incidence of postoperative nausea and vomiting

    Time frame: from the ending of surgery to 24 hours after surgery

    postoperative nausea and vomiting is recorded according to follow-up visits after surgery

Secondary outcomes

  1. intensity of postoperative nausea

    Time frame: from the ending of surgery to 24 hours after surgery

    intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)

  2. incidence of postoperative vomiting

    Time frame: from the ending of surgery to 24 hours after surgery

    postoperative vomiting is recorded according to follow-up visits after surgery

  3. incidence of intervention requirement for nausea and vomiting

    Time frame: from the ending of surgery to 24 hours after surgery

    this event is recorded according to follow-up visits after surgery

Other outcomes

  1. Postoperative pain intensity

    Time frame: from the ending of surgery to 24 hours after surgery

    Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)

  2. Postoperative analgesic requirements

    Time frame: from the ending of surgery to 24 hours after surgery

    Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump

  3. degree of satisfaction

    Time frame: from the ending of surgery to 24 hours after surgery

    degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)

  4. adverse reaction related to glycopyrronium and ondansetron

    Time frame: from the ending of surgery to 24 hours after surgery

    adverse reaction is recorded according to follow-up visits after surgery

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.