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

February 15, 2025 updated by: ismail aytaç, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort A: statin-use
Diagnostic test: 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.
Cohort B: statin-nonuse
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Chair: Emine Emen, ass. Dr., Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2025

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-24-830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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