Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Tianjin Nankai Hospital

Status: Not yet enrolling

Conditions: Intra-abdominal Hypertension

Treatments: Drug: Cisatracurium Besylate; Drug: saline 0.12ml/kg/hr

Study type: Interventional

Funder types: Other

Identifiers

NCT05172531

NKYY-IAH-2021-12

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Intra-abdominal pressure≥12mmHg
2. Age ≥18 years old
3. Obtain informed consent.

Exclusion criteria

1. Pregnancy pancreatitis
2. Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension
3. Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.)
4. Those who refuse to participate in the research

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

test group

Experimental group

Description:

Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation

Treatment:

Drug: Cisatracurium Besylate

control group

Sham Comparator group

Description:

Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation

Treatment:

Drug: saline 0.12ml/kg/hr