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| Name | Class |
|---|---|
| Chongqing General Hospital | OTHER |
| Chongqing Medical University | OTHER |
| The People's Hospital of DAZU ，Chongqing | UNKNOWN |
| The People's Hospital of Chongqing Kaizhou District |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrronium in Combination With Tropisetron | Experimental |
| |
| Normal Saline in Combination With Tropisetron | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium in Combination With Tropisetron | Drug | Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| intensity of postoperative nausea | intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness) | from the ending of surgery to 24 hours after surgery |
| incidence of postoperative vomiting |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity | Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain) | from the ending of surgery to 24 hours after surgery |
| Postoperative analgesic requirements |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| He Huang, MD | The Second Affiliated Hospital, Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40859968 | Derived | Chen J, Piao G, Luan G, Yu Y, Zheng W, Li Y, Zhang C, Duan Y, Zhao M, Zhang Y, Xiang W, Cheng L, Ji C, Duan G, Huang H. Effects of Glycopyrronium Bromide as an Adjuvant Treatment in the Prevention of Nausea and Vomiting After Abdominal, Thyroid, and Breast Surgery: A Multicenter Randomized Controlled Trial. Drug Des Devel Ther. 2025 Aug 19;19:7123-7134. doi: 10.2147/DDDT.S515670. eCollection 2025. |
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The individual participant data for this study is available from the sponsor on reasonable request through email.
Within five years
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| UNKNOWN |
| Fuling Hospital affiliated to Chongqing University | UNKNOWN |
| Qianjiang Central Hospital of Chongqing | UNKNOWN |
| Stomatological Hospital of Chongqing Medical University | UNKNOWN |
| People's Hospital of Changshou Chongqing | UNKNOWN |
| The Ninth People's Hospital of Chongqing | UNKNOWN |
| The First People's Hospital Of Chongqing Liang Jiang New Area | UNKNOWN |
| People's Hospital of Xiushan County | UNKNOWN |
| Wushan County People's Hospital | UNKNOWN |
| Three Gorges Hospital of Chongqing University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University | UNKNOWN |
| The People's Hospital of Nanchuan | UNKNOWN |
| Chongqing Traditional Chinese Medicine Hospital | OTHER |
| People's Hospital of Shapingba District， Chongqing | UNKNOWN |
| Chongqing Liangping District People's Hospital | UNKNOWN |
| Chongqing Jiangbei Hospital of Traditional Chinese Medicine | OTHER_GOV |
| People's Hospital of Chongqing Hechuan | UNKNOWN |
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| Normal Saline in Combination With Tropisetron | Drug | Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery. |
|
postoperative vomiting is recorded according to follow-up visits after surgery |
| from the ending of surgery to 24 hours after surgery |
| incidence of intervention requirement for nausea and vomiting | this event is recorded according to follow-up visits after surgery | from the ending of surgery to 24 hours after surgery |
Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump
| from the ending of surgery to 24 hours after surgery |
| degree of satisfaction | degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction) | from the ending of surgery to 24 hours after surgery |
| adverse reaction related to glycopyrronium and ondansetron | adverse reaction is recorded according to follow-up visits after surgery | from the ending of surgery to 24 hours after surgery |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D000077526 | Tropisetron |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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