Sugammadex Versus Neostigmine in Patients With Liver Cirrhosis Undergoing Liver Resection

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics. Rocuronium onset time is longer and recovery time from it is prolonged in cirrhotic patients than in those with normal liver function.

This randomized controlled study is designed to compare the pharmacodynamic profiles of sugammadex and neostigmine when used for the antagonism of moderate degree of rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and in patients with preoperative normal liver functions undergoing liver resection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Collaborator: National Liver Institute, Egypt
• Treatments: Atropine; Liver Extracts; Neostigmine; Rocuronium

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists physical status (ASA) class I for patients with preoperative normal liver function test (two groups) and I-III for patients with liver cirrhosis (two groups).

• For the two "Liver Cirrhosis" groups: Patients with liver Cirrhosis with Child classification "A" and a Model for End-Stage Liver Disease (MELD) score <10 undergoing Liver resection surgeries.

• For the two "Normal Liver" groups: Patients with normal preoperative liver functions undergoing Liver resection surgeries.

Exclusion Criteria:

• Co-existing neuromuscular disease.

• Body mass index more than 35 kg/m-2.

• Renal impairment.

• Medications known to affect neuromuscular transmission (e.g. Aminoglycoside antibiotics or Magnesium Sulphate).

• Bleeding tendency.

• Intra-operative adverse events (e.g. massive bleeding or hypothermia).