Effect of Ulinastatin on the Action of NDMRs (Rocuronium / Cisatracurium)

NCT05716256 | Completed DMC

• 1 other identifier: TJ-IRB20221241
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research was to determine the influence of ulinastatin on nondepolarising muscle relaxants Rocuronium and Cisatracurium.

Conditions

Nondepolarising Muscle Relaxants

Keywords

Ulinastatin; Rocuronium; Cisatracurium; Train of four (TOF)

Outcome Measures

Primary Outcomes (1)

• Duration 25%

  Duration 25% defined as the time from start of injection of neuromuscular blocker to T1 recovery to 25%.

  All measurements were performed before the creation of pneumoperitoneum

Secondary Outcomes (9)

• Onset time

  All measurements were performed before the creation of pneumoperitoneum

• RT1

  All measurements were performed before the creation of pneumoperitoneum

• RT2

  All measurements were performed before the creation of pneumoperitoneum

• RT3

  All measurements were performed before the creation of pneumoperitoneum

• RT4

  All measurements were performed before the creation of pneumoperitoneum

Study Arms (2)

Rocuronium

EXPERIMENTAL

The Rocuronium groups received ulinastatin 5000U/kg or saline 0.1 mL/kg followed by rocuronium 0.6 mg/kg

Drug: Ulinastatin; Drug: Placebo Comparator (0.9% NaCl)

Cisatracurium

EXPERIMENTAL

The Cisatracurium groups received ulinastatin 5000U/kg or normal saline 0.1 ml/kg followed by cisatracurium 0.1 mg/kg

Drug: Ulinastatin; Drug: Placebo Comparator (0.9% NaCl)

Interventions

Ulinastatin DRUG

The ulinastatin groups received ulinastatin 5000U/kg two minutes before the administration of muscle relaxants

Cisatracurium; Rocuronium

Placebo Comparator (0.9% NaCl) DRUG

The saline control groups received normal saline 0.1ml/kg two minutes before the administration of muscle relaxants

Cisatracurium; Rocuronium

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergo elective pancreaticoduodenectomy surgery
• Age ranging from 25 to 60 years，body mass index (BMI)18-24kg/m2, American Society of Anesthesiologists (ASA) grades 1 or 2.
• Receive general anesthesia and muscle relaxants intraoperatively.

You may not qualify if:

• patients ASA class 3 and above
• Severe cardiac or respiratory diseases, liver( Child-Pugh class B or C ) or kidney disease( estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m²)
• Pregnant women.
• Patients with neurological dysfunction including myasthenia gravis, epilepsy or psychiatric disorders
• Patients on any premedications including antisialagogues .
• 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
• Patients known allergy to propofol and sufentanil or remifentanil,
• emergency operations.
• Patients judged by the investigator to be unsuitable for participation in this study

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

urinastatin

Study Officials

• Xu Hui

  Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ai Ling, Doctor

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 8, 2023
• Study Start: February 15, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 25, 2023
• Last Updated: July 8, 2026

Record last verified: 2023-02

Locations

CN (1)