Skip to content

Effect of Neostigmine (drug) in Critically ill Cirrhotics (liver disease).

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068505
Enrollment
48
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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 more than 500ml, abdominal distension, bowel distension on abdominal imaging, and absence of bowel sounds.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution.Timepoint: Within 24 hours

Secondary

MeasureTime frame
Adverse effects related to the treatment and need for atropine usageTimepoint: 7 days;Calorie intake in 7 daysTimepoint: 7 days;Change in intra-abdominal pressure after resolution (IAP before and after)Timepoint: 24 hours;Change in SOFA score, APACHE scoreTimepoint: 7 days;New onset organ failure,New onset SBP,New onset infections,Need for rescue treatment.Timepoint: 7 days;Proportion of patients having passage of stool after intravenous neostigmine within 24-hours.Timepoint: 24 hours;Proportion of patients showing radiological resolution within 48-Hours and 72- hoursTimepoint: within 48-Hours and 72- hours;Serial change in gastric residual volumes (GRV)Timepoint: 24 hours;Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank).Timepoint: 7 days;Survival at 7-daysTimepoint: 7 days;Time to passage of stool in between two groupsTimepoint: 24 hours

Countries

India

Contacts

Public ContactDr V Rajan

Institute of Liver and Biliary Sciences

rajanvf40@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026