NCT06462872

To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics

To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics-Prospective Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aim: To determine the efficacy of intravenous neostigmine in the resolution of acute GI paralysis in patients with Critically Ill Cirrhosis (CIC). Study population: Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance. Study period - 1 years Sample Size • All the consecutive patients admitted in liver ICU during the study time period (Dec 2023 -September 2024) will be screened and those patients meeting with inclusion and exclusion criteria will be enrolled, we intend to enroll 70 patients for the study.

Detailed description

Study Design: Prospective observational study Intervention: Standard medical treatment (SMT)- keeping patients Nil Per Oral, I.V fluids, I.V antibiotics (antibiotic as per ICU protocol of ILBS), Ryle's tube decompression, correction of dyselectrolytemia, prokinetics * Patient to receive slow intravenous infusion of Neostigmine, 1 mg over 5-10 minutes repeated 8 hourly for first 24 hours. * Administration of Neostigmine will include defined steps for prevention of adverse event: * Neostigmine, 1 mg, intravenous infusion over 3-5 min * Atropine available at bedside Patient kept supine * Continuous electrocardiographic monitoring with vital signs for30 min * Continuous clinical assessment for 15-30 min Patients who do not give consent for the intervention will receive the standard of care treatment. Rescue treatment- Colonoscopic decompression, Flatus tube insertion, surgical intervention Monitoring and assessment: . An immediate clinical response was defined as the passage of flatus or stool with reduction in abdominal distention on physical examination after the injection. With clinical and radiological confirmation of resolution and re-initiation of enteral feeding, would define clinical response.

Conditions

• Critically Ill Cirrhotics

Interventions

Type	Name	Description
OTHER	observational study	It is an observational study

Timeline

• Start date: 2024-06-15
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2024-06-17
• Last updated: 2024-06-17

Locations

1 site across 1 country: India