NCT05172531

Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tianjin Nankai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blinded, controlled design. In this study, Cisatracurium Besylate was selected for treatment in Intra-abdominal hypertension or abdominal compartment syndrome,accompanied with evaluating the effects on the duration of organ failure,length of hospital stay and mortality.To clarify the effect of Cisatracurium Besylate on IAH/ACS is of great significance to the clinical applications.

Detailed description

1. Title: Title: Efficacy and Safety Profile of Cisatracurium Besylate on Intra-abdominal hypertension: A Randomized Clinical Trial 2. Research center: single center 3. Design of the research: A randomized, double-blind and parallel controlled study 4. Object of the research: The patients over 18 years that Intra-abdominal pressure over 12mmHg. 5. Sample size of the research: A total of 80patients,40 cases in each group 6. Interventions: Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation.while participants in the control group was the same as the test group except for received the same volume of saline instead of Cisatracurium Besylate.TOF-Watch was used to monitor the function of nerve and muscle in two groups and the dose was adjusted according to the TOF value. 7. The aim of the research:To investigate the effect of Cisatracurium Besylate on IIntra-abdominal hypertension or abdominal compartment syndrome. 8. Outcome #Primary outcomes: mortality. Secondary outcomes: Duration of organ failure; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay 9. The estimated duration of the study#1-2years

Conditions

• Intra-abdominal Hypertension

Interventions

Type	Name	Description
DRUG	Cisatracurium Besylate	Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。
DRUG	saline 0.12ml/kg/hr	saline 0.12ml/kg/hr

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-01-30
• Completion: 2023-04-01
• First posted: 2021-12-29
• Last updated: 2022-07-22