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

Sponsor

The Second Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05265507

Collaborator

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

480

Enrollment

Location

Arms

5.4

Anticipated Duration (Months)

89.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Glycopyrronium Drug: Ondansetron	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study

Actual Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glycopyrronium Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.	Drug: Glycopyrronium Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
Active Comparator: Ondansetron Ondansetron (4mg) was intravenously given at the ending of the surgery.	Drug: Ondansetron Glycopyrronium (4mg) was intravenously given at the ending of the surgery.

Arm

Intervention/Treatment

Experimental: Glycopyrronium

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

Drug: Glycopyrronium

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

Active Comparator: Ondansetron

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

Drug: Ondansetron

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

Outcome Measures

Primary Outcome Measures

incidence of postoperative nausea and vomiting [from the ending of surgery to 24 hours after surgery]
postoperative nausea and vomiting is recorded according to follow-up visits after surgery

Secondary Outcome Measures

intensity of postoperative nausea [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)
incidence of postoperative vomiting [from the ending of surgery to 24 hours after surgery]
postoperative vomiting is recorded according to follow-up visits after surgery
incidence of intervention requirement for nausea and vomiting [from the ending of surgery to 24 hours after surgery]
this event is recorded according to follow-up visits after surgery

Other Outcome Measures

Postoperative pain intensity [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)
Postoperative analgesic requirements [from the ending of surgery to 24 hours after surgery]
Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump
degree of satisfaction [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)
adverse reaction related to glycopyrronium and ondansetron [from the ending of surgery to 24 hours after surgery]
adverse reaction is recorded according to follow-up visits after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 ondansetron
Participate in other clinical drug trials within three months
Can not follow with the study procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing	China	400010

Sponsors and Collaborators

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

Investigators

Principal Investigator: He Huang, MD, The Second Affiliated Hospital, Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Second Affiliated Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT05265507

Other Study ID Numbers:

Glycopyrronium and ondansetron

First Posted:

Mar 3, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Nausea

Vomiting

Postoperative Nausea and Vomiting

Glycopyrrolate

Ondansetron

Study Results

No Results Posted as of Mar 31, 2022