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

NCT05716256 | Unknown DMC

• 1 other identifier: TJ-IRB20221241
• Study Type: interventional
• Target: 80
• 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 (10)

• Onset time

  Onset time defined as the period from start of injection of neuromuscular blocker to the time point when T1 has depressed to 5% of its initial control value.

  1 day

• RT1

  RT1 defined as the time from start of injection of neuromuscular blocker to T1 reappearance.

  1 day

• RT2

  Duration of moderate neuromuscular block (RT1-RT4)

  1 day

• RT3

  RT3 defined as the time from start of injection of neuromuscular blocker to T3 reappearance

  1 day

• RT4

  RT4 defined as the time from start of injection of neuromuscular blocker to T4 reappearance

  1 day

• Duration of moderate neuromuscular block (RT1-RT4)

  Duration of moderate neuromuscular block (RT1-RT4) defined as the time from reappearance of T1 to reappearance of T4.

  1 day

• Duration 25%

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

  1 day

• Duration 50%

  Duration 50% defined as the time from start of injection of neuromuscular blocker to T1 recovery to 50%.

  1 day

• Duration TOF 0.7

  Duration TOF 0.7 defined as the time from start of neuromuscular blocker injection to recovery of TOF ratio to 0.7.

  1 day

• Recovery TOF 0.7 period

  Recovery TOF 0.7 period defined as the time from reappearance of T4 to recovery of TOF ratio to 0.7.

  1 day

Study Arms (2)

Ulinastatin

EXPERIMENTAL

The experimental groups （Rocuronium-Ulinastatin group and Cisatracurium-Ulinastatin group）received ulinastatin 5000U/kg followed by rocuronium 0.6 mg/kg or cisatracurium 0.1 mg/kg

Drug: Ulinastatin; Procedure: TOF monitoring

Conventional treatment group

SHAM COMPARATOR

The control groups（Rocuronium-Saline group and Cisatracurium-Saline group） received normal saline 0.1ml/kg followed by rocuronium 0.6 mg/kg or cisatracurium 0.1 mg/kg

Drug: Ulinastatin; Procedure: TOF monitoring

Interventions

Ulinastatin DRUG

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

Conventional treatment group; Ulinastatin

TOF monitoring PROCEDURE

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.

Conventional treatment group; Ulinastatin

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 or kidney disease
• 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

Central Study Contacts

Ai Ling

CONTACT

+8613667135571; aileen911@126.com

Xu Hui

CONTACT

+8613971001596

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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: February 8, 2023

Record last verified: 2023-02

Locations

CN (1)