NCT04906317

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Colonoscopy
• Sedation and Analgesia

Interventions

Type	Name	Description
DRUG	midazolam and dezocine	Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level
DRUG	Propofol	standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-12-31
• Completion: 2024-12-12
• First posted: 2021-05-28
• Last updated: 2021-05-28

Locations

1 site across 1 country: China