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

NCT06834776 | Not Yet Recruiting

• 1 other identifier: TABED 1-24-830
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromuscular Blockade; Statin-Associated Myopathy; Neuromuscular Monitoring

Outcome Measures

Primary Outcomes (3)

• Time to reach TOF count 0

  time from administration of rocuronium to reach TOF count 0

  0th minute

• Time to reach TOF 40

  time to intraoperatively TOF reached 40

  about 40th minute

• Time to reach TOF 90 (reversal of neuromuscular blockade)

  Measured postoperatively after sugammadex administration and additional doses if required.

  about 60th minute

Study Arms (2)

cohort A: statin-use

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

Cohort B: statin-nonuse

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

Interventions

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.

Cohort B: statin-nonuse; cohort A: statin-use

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Officials

• Emine Emen, ass. Dr.

  Ankara City Hospital Bilkent

  STUDY CHAIR

Central Study Contacts

ismail aytaç, assoc. Prof. Dr

CONTACT

+905056340369; aytacismail1972@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 19, 2025
• Study Start: February 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-12