Clinical trial NCT04906317: The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps
Official title: The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps: a Single-center, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Sedation and Analgesia
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The score of visual analogue scoring (VAS)
timeFrame: immediately after the procedure of colonoscopy
Secondary outcomes:
measure: Treatment fee
timeFrame: During the colonoscopy procedure
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Six Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Xuefeng Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: