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

Not yet recruiting

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

• Registration Number: NCT06834776
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-31
• Study Start: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-11-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to reach TOF 40	about 40th minute	time to intraoperatively TOF reached 40
Time to reach TOF count 0	0th minute	time from administration of rocuronium to reach TOF count 0
Time to reach TOF 90 (reversal of neuromuscular blockade)	about 60th minute	Measured postoperatively after sugammadex administration and additional doses if required.