CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Neostigmine Methylsulfate 1 MG/ML +1 moredrug
Likely dose
Neostigmine Methylsulfate 1 MG/MLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02543658
NCT02543658Phase 2Completed

The Curative Effect and Security of Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension

The First Affiliated Hospital of Nanchang University·interventional·Posted Sep 7, 2015·Updated Oct 5, 2021

In Brief

A Phase 2 clinical trial evaluating Neostigmine Methylsulfate 1 MG/ML and Conservative treatment for Acute Pancreatitis and Intra-abdominal Hypertension. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Acute pancreatitis(A) often complicated with Intra-abdominal Hypertension. After the onset of acute pancreatitis, capillary leakage causing ascites,upper gastrointestinal tract obstruction and paralytic ileus leading to an elevated IAP, severe IAH leads to ACS with high mortality. Neostigmine is an anti-cholinesterase drugs, can enhance intestinal peristalsis, promote flatus defecation. The aim of this study was to determine the effect of neostigmine on reducing abdominal pressure and clinical prognosis in patients with AP by promoting intestinal peristalsis and defecation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartSep 1, 2015
Primary CompletionAug 15, 2017
Study CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.8 years ago

Interventions

Neostigmine Methylsulfate 1 MG/MLdrug

The initial dose was 1mg, intramuscular injection(IM) once every 12 hours. If there is no defecation after 12 hours, the dose is increased to 1mg IM once every 8 hours; if there is no defecation after 24 hours, the dose is increased to 1mg IM once every 6 hours. If the abdominal pressure drops below 12mmhg, neostigmine will be stopped, otherwise it will be used continuously for 7 days.

Conservative treatmentcombination

Intragastric administration of paraffin oil, 50ml,once every 8 hours;gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.