Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462872
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-04
Brief Title:
To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics-Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 IV fluids IV antibiotics antibiotic as per ICU protocol of ILBS Ryles 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
Intervention Standard medical treatment SMT- keeping patients Nil Per Oral IV fluids IV antibiotics antibiotic as per ICU protocol of ILBS Ryles 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None