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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06834776
Enrollment
104
Registered
2025-02-19
Start date
2025-02-15
Completion date
2025-12-15
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade, Neuromuscular Monitoring, Statin-Associated Myopathy

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.

Interventions

DIAGNOSTIC_TESTTOF (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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to reach TOF count 00th minutetime from administration of rocuronium to reach TOF count 0
Time to reach TOF 40about 40th minutetime to intraoperatively TOF reached 40
Time to reach TOF 90 (reversal of neuromuscular blockade)about 60th minuteMeasured postoperatively after sugammadex administration and additional doses if required.

Contacts

Primary Contactismail aytaç, assoc. Prof. Dr
aytacismail1972@gmail.com+905056340369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026