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

NCT ID: NCT06834776

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-12-15

Brief Summary

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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

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Conditions

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Neuromuscular Blockade Statin-Associated Myopathy Neuromuscular Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cohort A: statin-use

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

Intervention Type DIAGNOSTIC_TEST

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

Cohort B: statin-nonuse

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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TOF (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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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ismail aytaƧ

Ass. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine Emen, ass. Dr.

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Central Contacts

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ismail aytaƧ, assoc. Prof. Dr

Role: CONTACT

+905056340369

Other Identifiers

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TABED 1-24-830

Identifier Type: -

Identifier Source: org_study_id

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