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

Primary Purpose

Colonoscopy, Sedation and Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
midazolam and dezocine
Propofol
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Six Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sedation and Analgesia

Anesthesia

Arm Description

0.05 mg/kg midazolam and 5mg dezocine iv infusion

continuous 1.5mg/kg propofol iv infusion

Outcomes

Primary Outcome Measures

The score of visual analogue scoring (VAS)
Assess immediately after the completement of colonoscopy

Secondary Outcome Measures

Treatment fee
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

Full Information

First Posted
May 25, 2021
Last Updated
May 27, 2021
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04906317
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Sedation and Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sedation and Analgesia
Arm Type
Active Comparator
Arm Description
0.05 mg/kg midazolam and 5mg dezocine iv infusion
Arm Title
Anesthesia
Arm Type
Active Comparator
Arm Description
continuous 1.5mg/kg propofol iv infusion
Intervention Type
Drug
Intervention Name(s)
midazolam and dezocine
Other Intervention Name(s)
Not necessary
Intervention Description
Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Not necessary
Intervention Description
standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level
Primary Outcome Measure Information:
Title
The score of visual analogue scoring (VAS)
Description
Assess immediately after the completement of colonoscopy
Time Frame
immediately after the procedure of colonoscopy
Secondary Outcome Measure Information:
Title
Treatment fee
Description
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
Time Frame
During the colonoscopy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiancong Hu, MD
Phone
+86 02038476875
Email
hujianc@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefeng Guo, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Six Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiancong Hu, MD
Phone
+86 02038476875
Email
hujianc@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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