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

NCT04906317 | Unknown DMC

• 1 other identifier: 2021ZSLYEC-028
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonoscopy; Sedation and Analgesia

Outcome Measures

Primary Outcomes (1)

• The score of visual analogue scoring (VAS)

  Assess immediately after the completement of colonoscopy

  immediately after the procedure of colonoscopy

Secondary Outcomes (1)

• Treatment fee

  During the colonoscopy procedure

Study Arms (2)

Sedation and Analgesia

ACTIVE COMPARATOR

0.05 mg/kg midazolam and 5mg dezocine iv infusion

Drug: midazolam and dezocine

Anesthesia

ACTIVE COMPARATOR

continuous 1.5mg/kg propofol iv infusion

Drug: Propofol

Interventions

midazolam and dezocine DRUG

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

Also known as: Not necessary

Sedation and Analgesia

Propofol DRUG

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

Also known as: Not necessary

Anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Six Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Midazolam; dezocine; Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xuefeng Guo, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiancong Hu, MD

CONTACT

+86 02038476875; hujianc@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 12, 2024
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)