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

Sun Yat-sen University

Status: Enrolling

Conditions: Colonoscopy; Sedation and Analgesia

Treatments: Drug: Propofol; Drug: midazolam and dezocine

Study type: Interventional

Funder types: Other

Identifiers

NCT04906317

2021ZSLYEC-028

Details and patient eligibility

About

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

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Sedation and Analgesia

Active Comparator group

Description:

0.05 mg/kg midazolam and 5mg dezocine iv infusion

Treatment:

Drug: midazolam and dezocine

Anesthesia

Active Comparator group

Description:

continuous 1.5mg/kg propofol iv infusion

Treatment:

Drug: Propofol