Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing

Summary

Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.

Conditions

• Bowel Preparation for Colonoscopy

Interventions

DRUG

1L PEG + 50g magnesium sulfate

Subjects in Group A will use a regimen combining magnesium sulfate and polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. 1 litter of polyethylene glycol is taken at 8pm the day before the colonoscopy and 50 gram of magnesium sulfate is taken 4-6 hours before the colonoscopy, and then drink 2000 ml of water within 2 hours.

DRUG

3L PEG

Subjects in Group B will use a regimen with 3L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.

DRUG

4L PEG

Subjects in Group C will use a regimen with 4L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 4 liters of polyethylene glycol solution is taken in split dosing, with 2 liters taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Daping Hospital of Army Medical University

  collaborator OTHER

• Ningjin People's Hospital

  collaborator UNKNOWN

• Zibo Central Hospital

  collaborator OTHER_GOV

• Zhengzhou Central Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Affiliated Yueqing Hospital of Wenzhou Medical University

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• The General Hospital of Western Theater Command

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Science and Technology

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• The Fifth Affiliated Hospital of Zunyi Medical College

  collaborator OTHER

• Yan'an University Affiliated Hospital

  collaborator OTHER

• 900 Hospital of Joint Logistics Support Force of PLA

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhaoshen Li, MD · Changhai Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-09

Primary Completion

2025-08-31

Completion

2025-08-31