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

NCT ID: NCT04906317

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-12-12

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.

Conditions

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Colonoscopy Sedation and Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sedation and Analgesia

0.05 mg/kg midazolam and 5mg dezocine iv infusion

Group Type ACTIVE_COMPARATOR

midazolam and dezocine

Intervention Type DRUG

Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level

Anesthesia

continuous 1.5mg/kg propofol iv infusion

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level

Interventions

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midazolam and dezocine

Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level

Intervention Type DRUG

Propofol

standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level

Intervention Type DRUG

Other Intervention Names

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Not necessary Not necessary

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xuefeng Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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The Six Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiancong Hu, MD

Role: CONTACT

Phone: +86 02038476875

Email: [email protected]

Facility Contacts

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Jiancong Hu, MD

Role: primary

Other Identifiers

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2021ZSLYEC-028

Identifier Type: -

Identifier Source: org_study_id