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

Ankara City Hospital

Status: Not yet enrolling

Conditions: Statin-Associated Myopathy; Neuromuscular Monitoring; Neuromuscular Blockade

Treatments: Diagnostic Test: TOF (Train-of-Four) monitoring for depth of neuromuscular blockade.

Study type: Observational

Funder types: Other

Identifiers

NCT06834776

TABED 1-24-830

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

104 participants in 2 patient groups

cohort A: statin-use

Treatment:

Diagnostic Test: TOF (Train-of-Four) monitoring for depth of neuromuscular blockade.

Cohort B: statin-nonuse

Treatment:

Diagnostic Test: TOF (Train-of-Four) monitoring for depth of neuromuscular blockade.