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

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.

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Key information

Conditions

Neuromuscular Blockade Neuromuscular Monitoring Statin-Associated Myopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

General anesthesia with propofol and fentanyl induction followed by rocuronium for neuromuscular blockade; maintenance with desflurane and remifentanil.

Primary outcomes

Time to reach TOF count 0

Time frame: 0th minute

time from administration of rocuronium to reach TOF count 0
Time to reach TOF 40

Time frame: about 40th minute

time to intraoperatively TOF reached 40
Time to reach TOF 90 (reversal of neuromuscular blockade)

Time frame: about 60th minute

Measured postoperatively after sugammadex administration and additional doses if required.

Study contacts

Contact information is provided by the study sponsor or research team.

ismail aytaç, assoc. Prof. Dr

CONTACT

[email protected]

+905056340369

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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)

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 19, 2025
Registry last updated: Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed