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Clinical trial

Effect of Ulinastatin on the Action of Nondepolarising Muscle Relaxants Rocuronium / Cisatracurium

ID
Name
TJ-IRB20221241
Description
The aim of this research was to determine the influence of ulinastatin on nondepolarising muscle relaxants Rocuronium and Cisatracurium.
Trial arms
Trial start
2023-02-15
Estimated PCD
2023-06-15
Trial end
2023-06-25
Status
Not yet recruiting
Treatment
Ulinastatin
The CIS-ULI group received ulinastatin 5000U/kg followed by cisatracurium 0.1 mg/kg The CIS-NS (control) group received normal saline 0.1ml/kg followed by cisatracurium 0.1 mg/kg. The ROC-ULI group received ulinastatin 5000U/kg followed by rocuronium 0.6 mg/kg The ROC-NS (control) group received normal saline 0.1ml/kg followed by rocuronium 0.6 mg/kg
Arms:
Conventional treatment group, Ulinastatin
TOF monitoring
The acceleromyograph TOF-Watch® SX (Organon, Ireland) is used for TOF monitoring. When the Narcotrend™ index is below 50 and level of anesthesia assessed as deep enough, TOF stimulation is started at 50 mA amplitudes and the setup is checked for any problem concerning the electrodes impedance and local hand temperature. After 1 minute, TOF stimulation is stopped and a tetanic stimulation (each electrical stimulus of 200μs duration and 50 mA amplitude) is delivered at a frequency of 50Hz for 5 seconds. After this procedure the alignment of sensors are checked to see if they are intact and readjust to their initial position if necessary. A no stimulation pause is observed during 3 minutes.
Arms:
Conventional treatment group, Ulinastatin
Size
80
Primary endpoint
Onset time
1 day
RT1
1 day
RT2
1 day
RT3
1 day
RT4
1 day
Duration of moderate neuromuscular block (RT1-RT4)
1 day
Duration 25%
1 day
Duration 50%
1 day
Duration TOF 0.7
1 day
Recovery TOF 0.7 period
1 day
Eligibility criteria
Inclusion Criteria: 1. Patients undergo elective pancreaticoduodenectomy surgery 2. Age ranging from 25 to 60 years，body mass index (BMI)18-24kg/m2, American Society of Anesthesiologists (ASA) grades 1 or 2. 3. Receive general anesthesia and muscle relaxants intraoperatively. Exclusion Criteria: 1. patients ASA class 3 and above 2. Severe cardiac or respiratory diseases, liver or kidney disease 3. Pregnant women. 4. Patients with neurological dysfunction including myasthenia gravis, epilepsy or psychiatric disorders 5. Patients on any premedications including antisialagogues . 6. Patients on drugs known to interfere with neuromuscular transmission including but not exclusive to anticonvulsants, calcium channel blockers, β-blockers, corticosteroids, diuretics and antibiotics of the aminoglycoside group 7. Patients known allergy to propofol and sufentanil or remifentanil, 8. emergency operations. 9. Patients judged by the investigator to be unsuitable for participation in this study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-02-08

1 organization

1 drug

1 indication

Organization
Huazhong University of Science and Technology
Drug
Ulinastatin
Indication
Non-depolarizing muscle relaxants