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Time Interval After Gastric Emptying and Quality of Bowel Cleansing

NCT ID: NCT06111937

Last Updated: 2025-12-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-30

Brief Summary

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The goal of this \[clinical trial\] is to \[explore the balance time point between the waiting time for intestinal preparation after gastric emptying and quality of bowel preparation.\] in \[patients with painless colonoscopy\]. The main question\[s\] it aims to answer are:

\[whether the gastric is empty or not 2 hours after finishing drinking 1.5 L of MgSO4 solution within 2 hours\] \[whether the quality of patients' bowel preparation is superior in a time period of 2-4 hours after finishing drinking 1.5 L of MgSO4 solution\] Participants will \[ be asked finishing the last dose of 1.5 L MgSO4 solution within 2 hours and received ultrasound gastric assessment immediately 2 or 4 hours after finishing drinking MgSO4 solution in a 15 minutes time interval until the gastric is empty. As soon as the gastric is empty, patients receive painless colonoscopy within 2 hours or 2-4 hours.

Researchers will compare \[patients receiving painless colonoscopy within 2 hours or 2-4 hours after finishing drinking 1.5 L of MgSO4 solution\] to see if \[the quality of patients' bowel preparation is superior in a time period of within 2 hours\].

Detailed Description

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All subjects ate a light diet the day before the examination and fasted after 19:00 on the night before examination. A segmented intestinal cleansing regimen of 3L MgSO4 was adopted: 1.5L was taken one night before the examination; On the day of the examination, the second dose of 1.5L was taken and finished within 2 hours. The medication method was guided by professional nursing staff. All subjects were instructed to take appropriate activities during the administration of intestinal cleanser to promote excretion. Patients were divided into two groups (group A and group B) using random number table method. Patients in group A received gastric ultrasound examination every 15 minutes 2 hours immediately after taking the last dose of MgSO4 solution. During this period, if the gastric ultrasound showed that the patient had an "empty stomach", and painless colonoscopy was performed within 2 hours while the gastric is empty. If the gastric ultrasound still showed "full stomach" at 4h, the patient was abandoned, but gastric ultrasound assessment continued until the stomach was empty. The patients in group B received gastric ultrasound examination every 15min 4h immediately after taking the last dose of MgSO4 solution on the examination day, and colonoscopy was to completed within 4-6h after taking the MgSO4 solution if the gastric ultrasound showed that the patient had an "empty stomach". If the gastric ultrasound still shows "full stomach" at 6h, it is eliminated, but continuing to perform gastric ultrasound every 15min until the " stomach was empty ". All patients received general anesthesia by the same senior anesthesiologist using propofol 2 mg/kg and remifentanil 0.2 ug/kg. The BIS value of anesthesia depth was controlled in the range of 40-60, and propofol and remifentanil were added as needed. The same chief gastroenterologist performed the colonoscopy and evaluated the quality of intestinal cleaning.

Conditions

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Colonoscopy

Keywords

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Colonoscopy Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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colonoscopy within 2-4 h

Patients received ultrasound gastric assessment every 15 minutes 2 hours immediately after taking the last dose of MgSO4 solution. During this period, if the gastric ultrasound assessment showed that the patient had an "empty stomach", and painless colonoscopy was performed within 2 hours while the gastric is empty.

Group Type EXPERIMENTAL

after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours

Intervention Type OTHER

Patients received gastric ultrasound examination every 15 minutes 2 or 4 hours immediately after taking the last dose of MgSO4 solution in group A or B respectively.

colonoscopy within 4-6 h

The patients received ultrasound gastric assessment every 15min 4h immediately after taking the last dose of MgSO4 solution on the examination day, and colonoscopy was to completed within 4-6h after taking the MgSO4 solution if the gastric ultrasound assessment showed that the patient had an "empty stomach".

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours

Patients received gastric ultrasound examination every 15 minutes 2 or 4 hours immediately after taking the last dose of MgSO4 solution in group A or B respectively.

Intervention Type OTHER

Other Intervention Names

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Ultrasound gastric assessment

Eligibility Criteria

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Inclusion Criteria

1.Patients who receiving elective colonoscopy under general anesthesia

Exclusion Criteria

1. Patients with severe heart and lung diseases who cannot tolerate anesthesia or colonoscopy
2. chronic constipation
3. history of gastric or intestinal surgery
4. diabetes, Parkinson's disease, stroke,
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gu JianPing

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Lee J, Kim TO, Seo JW, Choi JH, Heo NY, Park J, Park SH, Yang SY, Moon YS. Shorter waiting times from education to colonoscopy can improve the quality of bowel preparation: A randomized controlled trial. Turk J Gastroenterol. 2018 Jan;29(1):75-81. doi: 10.5152/tjg.2018.17467.

Reference Type RESULT
PMID: 29391311 (View on PubMed)

Tooson JD, Gates LK Jr. Bowel preparation before colonoscopy. Choosing the best lavage regimen. Postgrad Med. 1996 Aug;100(2):203-4, 207-12, 214. doi: 10.3810/pgm.1996.08.59.

Reference Type RESULT
PMID: 8700818 (View on PubMed)

Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.

Reference Type RESULT
PMID: 24893784 (View on PubMed)

Other Identifiers

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KY20230428-01

Identifier Type: -

Identifier Source: org_study_id