Postoperative Nausea and Vomiting
Conditions
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.
Interventions
DRUGGlycopyrronium
Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
DRUGOndansetron
Glycopyrronium (4mg) was intravenously given at the ending of the surgery.
Sponsors
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 Medical 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
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactGuangyou Duan, MD
Backup ContactDagang Wang, MD
Outcome results
None listed