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

Not Applicable

Recruiting

• Conditions: Sedation and Analgesia; Colonoscopy
• Interventions: Drug: midazolam and dezocine; Drug: Propofol

• Registration Number: NCT04906317
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-05-28
• Last Update Posted: 2021-05-28
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedation and Analgesia	midazolam and dezocine	0.05 mg/kg midazolam and 5mg dezocine iv infusion
Anesthesia	Propofol	continuous 1.5mg/kg propofol iv infusion

Primary Outcome Measures

Name	Time	Method
The score of visual analogue scoring (VAS)	immediately after the procedure of colonoscopy	Assess immediately after the completement of colonoscopy

Secondary Outcome Measures

Name	Time	Method
Treatment fee	During the colonoscopy procedure	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

Trial Locations

Locations (1)

The Six Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China