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Not yet recruiting NCT06834776

Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients

— Observational Neuromuscular Blockade Statin-Associated Myopathy Neuromuscular Monitoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TOF (Train-of-Four) monitoring for depth of neuromuscular blockade..
Who it may be relevant to
Registry conditions: Neuromuscular Blockade, Statin-Associated Myopathy, Neuromuscular Monitoring. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia, Monitored by Train-of-Four (TOF)

Overview

This study aims to compare the neuromuscular blockade responses in patients undergoing elective surgery under general anesthesia, with a focus on the use of statins. The study will assess the depth of neuromuscular blockade, recovery time, and postoperative residual curarization using Train-of-Four (TOF) monitoring, with the primary goal of determining whether statin use alters the neuromuscular blockade management.

Interventions

  • Diagnostic test TOF (Train-of-Four) monitoring for depth of neuromuscular blockade.
    General anesthesia with propofol and fentanyl induction followed by rocuronium for neuromuscular blockade; maintenance with desflurane and remifentanil.

Primary outcome measures

  • Time to reach TOF count 0 [Time frame: 0th minute]
  • Time to reach TOF 40 [Time frame: about 40th minute]
  • Time to reach TOF 90 (reversal of neuromuscular blockade) [Time frame: about 60th minute]

Eligibility criteria

Inclusion criteria

  • Age 18-75 years
  • ASA classification I, II, III
  • BMI 18-30
  • Statin use for at least 3 months or no prior statin use
  • Elective surgery requiring general anesthesia with endotracheal intubation
  • Signed informed consent for participation in the study

Exclusion criteria

  • ASA classification IV or higher
  • BMI <18 or >30
  • History of liver or renal insufficiency (creatinine >1.6, liver function tests >2x normal)
  • Neuromuscular, psychiatric, or neurological disorders
  • Pregnancy
  • Use of drugs affecting neuromuscular function (e.g., anticonvulsants, aminoglycosides)
  • History of malignant hyperthermia
  • Respiratory disorders, including sleep apnea
  • Allergy to anesthetic drugs used in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06834776 · TABED 1-24-830

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗