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The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.
Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrrolate | Experimental | Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic. |
|
| Placebo | Placebo Comparator | Participants will receive intravenous 1ml saline while receiving anesthetic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate | Drug | Intravenous injection of glycopyrrolate 0.2mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intestinal spasm | The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter, 2 (fair): moderate spasm,lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm,the oral side lumen is not visible. | During Colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| inhibitory effect score | Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter, 2 (fair): moderate spasm,lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm,the oral side lumen is not visible. | During Colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guangyou Duan, doctor | The Second Affiliated Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Placebo |
| Other |
Intravenous injection of saline 1ml |
|
| Polyp Treatment Time |
Time from start of polyp removal to complete polyp removal. |
| During Colonoscopy |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |