The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

NCT04583111 — Phase 4, Unknown, 200 participants, RenJi Hospital
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT04583111
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment200 (Estimated)
SponsorRenJi Hospital (Other)
ConditionsBowel Preparation
InterventionsDomperidone, sulpiride (Drug)
Datesstart 2020-03-01, primary completion 2022-03-01 (estimated), completion 2022-03-01 (estimated), first posted 2020-10-12, last updated 2020-10-12
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Bowel Preparation All trials of Domperidone All trials of sulpiride

-Summary

Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Domperidone groupExperimentalDrug: DomperidonePatients in Domperidone group took 10mg of domperidone 30min before PEG.
Sulpiride groupExperimentalDrug: sulpiridePatients in Sulpiride group took 100mg of sulpiride 30min before PEG.
Control groupNo interventionPatients in Control group followed the regular routine of 3L split-dose of PEG.
  • Domperidone (Drug): Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
  • sulpiride (Drug): Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.

+Outcome measures

Primary outcomes

  • Incidence of the discomforts during bowel preparation [before colonoscopy]: The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts.

Secondary outcomes

  • The quality of bowel preparation assessed by Boston Bowel Preparation Scale [during colonoscopy]: The secondary endpoint was the quality of bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS) during the withdrawal phase of colonoscopy. The BBPS uses a 0-3 points scale assessing the bowel preparation quality in 3 segments of the colon (the right, transverse and left colons). BBPS score ≥ 6 were defined as adequate bowel preparation.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* 18-70 years patients scheduled for colonoscopy

Exclusion Criteria:

* intestinal obstruction or hemorrhage;
* allergy to domperidone, sulpiride or PEG;
* pregnancy or breastfeeding;
* previous use of prokinetics within 1 month.

+Locations (1)

FacilityCityCountryStatus
Shengliang ChenShanghaiChinaRecruiting