The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps

Study Overview
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Brief Summary
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This study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.

Detailed Description
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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.

Official Title
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The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps: a Single-center, Prospective, Randomized Controlled Study

Conditions
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Colonoscopy, Sedation and Analgesia

Intervention / Treatment
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* Drug: midazolam and dezocine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colonoscopy diagnosed as a colorectal polyp, the number of polyps is less than 5, and the size of single polyp is less than 2.0 cm Age more than 18 years and less than 70 years Exclusion Criteria: Allergy to propofol, dezocine, midazolam or eggs ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely Suspected of gastrointestinal perforation, bleeding or obstruction Acute gastrointestinal infection period History of abdominal surgery Patients during pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sedation and Analgesia<br>0.05 mg/kg midazolam and 5mg dezocine iv infusion | Drug: midazolam and dezocine<br>* Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level<br>* Other names: Not necessary;|
| Active Comparator: Anesthesia<br>continuous 1.5mg/kg propofol iv infusion | Drug: Propofol<br>* standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level<br>* Other names: Not necessary;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of visual analogue scoring (VAS) | Assess immediately after the completement of colonoscopy | immediately after the procedure of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | 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 |