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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glycopyrronium in Combination With Tropisetron
Normal Saline in Combination With Tropisetron
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glycopyrronium in Combination With Tropisetron

Normal Saline in Combination With Tropisetron

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

intensity of postoperative nausea
intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)
incidence of postoperative vomiting
postoperative vomiting is recorded according to follow-up visits after surgery
incidence of intervention requirement for nausea and vomiting
this event is recorded according to follow-up visits after surgery

Full Information

First Posted
April 11, 2022
Last Updated
October 19, 2023
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Chongqing General Hospital, Chongqing Medical University, 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, Three Gorges Hospital of Chongqing University, First Affiliated Hospital of Chongqing Medical University, Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University, The People's Hospital of Nanchuan, Chongqing Traditional Chinese Medicine Hospital, 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
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1. Study Identification

Unique Protocol Identification Number
NCT05331651
Brief Title
Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting
Official Title
Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Chongqing General Hospital, Chongqing Medical University, 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, Three Gorges Hospital of Chongqing University, First Affiliated Hospital of Chongqing Medical University, Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University, The People's Hospital of Nanchuan, Chongqing Traditional Chinese Medicine Hospital, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycopyrronium in Combination With Tropisetron
Arm Type
Experimental
Arm Title
Normal Saline in Combination With Tropisetron
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Glycopyrronium in Combination With Tropisetron
Intervention Description
Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.
Intervention Type
Drug
Intervention Name(s)
Normal Saline in Combination With Tropisetron
Intervention Description
Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.
Primary Outcome Measure Information:
Title
incidence of postoperative nausea and vomiting
Description
postoperative nausea and vomiting is recorded according to follow-up visits after surgery
Time Frame
from the ending of surgery to 24 hours after surgery
Secondary Outcome Measure Information:
Title
intensity of postoperative nausea
Description
intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)
Time Frame
from the ending of surgery to 24 hours after surgery
Title
incidence of postoperative vomiting
Description
postoperative vomiting is recorded according to follow-up visits after surgery
Time Frame
from the ending of surgery to 24 hours after surgery
Title
incidence of intervention requirement for nausea and vomiting
Description
this event is recorded according to follow-up visits after surgery
Time Frame
from the ending of surgery to 24 hours after surgery
Other Pre-specified Outcome Measures:
Title
Postoperative pain intensity
Description
Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)
Time Frame
from the ending of surgery to 24 hours after surgery
Title
Postoperative analgesic requirements
Description
Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump
Time Frame
from the ending of surgery to 24 hours after surgery
Title
degree of satisfaction
Description
degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)
Time Frame
from the ending of surgery to 24 hours after surgery
Title
adverse reaction related to glycopyrronium and ondansetron
Description
adverse reaction is recorded according to follow-up visits after surgery
Time Frame
from the ending of surgery to 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Organizational Affiliation
The Second Affiliated Hospital, Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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