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This study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.
Colorectal polyps are precancerous lesions of the colorectal cancer. Colonoscopy can reduce the risk of colorectal cancer. Painless endoscopy could reduce patient discomfort and improves the acceptance of treatment, especially for the endoscopic treatment of colorectal polyps. Intravenous anesthesia colonoscopy has a strong sedative effect and has obvious inhibitory effects on the respiratory and circulatory systems. It requires the assistance of an anesthesiologist. The lack of anesthesiologists makes it difficult to make an appointment for anesthesia colonoscopy, which is a bottleneck in the diagnosis and treatment of gastrointestinal diseases in China. Therefore, there is an urgent need to find a painless diagnosis and treatment method that is not inferior to anesthesia colonoscopy in comfort to meet the needs of patients. Comparing to anesthesia colonoscopy, sedative and analgesic colonoscopy have similar sedative and analgesic effects and do not require the assistance of an anesthesiologist. However, there is no relevant evaluation on the effectiveness of sedation and analgesia during the endoscopic treatment of colorectal polyps. Our department has used midazolam combined with dezocine to treat 185 patients with colorectal polyps in these years. Retrospective analysis showed that the sedative and analgesic effect is satisfactory. Therefore, it is necessary to make a single-center randomized parallel group controlled non-inferiority study to directly compare the effectiveness of sedation and analgesia versus intravenous anesthesia in endoscopic treatment of colorectal polyps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation and Analgesia | Active Comparator | 0.05 mg/kg midazolam and 5mg dezocine iv infusion |
|
| Anesthesia | Active Comparator | continuous 1.5mg/kg propofol iv infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam and dezocine | Drug | Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level |
|
| Measure | Description | Time Frame |
|---|---|---|
| The score of visual analogue scoring (VAS) | Assess immediately after the completement of colonoscopy | immediately after the procedure of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment fee | The fee of treatment refers to the total cost of anesthesia fee, anesthesia/sedation drug fee, intraoperative monitoring fee, endoscopy fee and endoscopic treatment fee | During the colonoscopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiancong Hu, MD | Contact | +86 02038476875 | hujianc@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xuefeng Guo, MD | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Six Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C010827 | dezocine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Propofol | Drug | standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level |
|
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |