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

Institute of Liver and Biliary Sciences, India

Status: Not yet enrolling

Conditions: Critically Ill Cirrhotics

Treatments: Other: observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06462872

ILBS-Cirrhosis-66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.
2. Patients with new onset lower GI tract paralysis with clinical presentation of feed intolerance defined as GRV> 500ml, abdominal distension, bowel distension on abdominal imaging, and absence of bowel sounds.

Exclusion criteria

1. Recent GI bleed
2. Bronchoconstriction
3. Bradycardia
4. Current or past history of surgical abdomen, including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery.
5. Prior comorbid illnesses like advanced cardiopulmonary disease, prior episodes of arrhythmia, structural heart diseases, traumatic brain injury, cerebrovascular accidents, raised intracranial pressures, history of myasthenia gravis.
6. Endocrinological illnesses like uncontrolled hypothyroidism, hypoparathyroidism
7. Connective tissue disorders including systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosus,amyloidosis.
8. Pregnant females
9. Refusal to give consent.

Trial design

48 participants in 1 patient group

Critically ill cirrhotics

Description:

Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.

Treatment:

Other: observational study