Neuromuscular BlockadeNCT06834776
Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients
An observational study of Neuromuscular Blockade and Statin-Associated Myopathy, run by Ankara City Hospital Bilkent.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade, Statin-Associated Myopathy, Neuromuscular Monitoring
- What is being tested?
- TOF (Train-of-Four) monitoring for depth of neuromuscular blockade.
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia
Who may be able to join
- 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
Who cannot join
- 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)
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- History of malignant hyperthermia
- Respiratory disorders, including sleep apnea
- Allergy to anesthetic drugs used in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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)
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.
- Being tested
- TOF (Train-of-Four) monitoring for depth of neuromuscular blockade.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| cohort A: statin-use | Not described Receives: Diagnostic Test: TOF (Train-of-Four) monitoring for depth of neuromuscular blockade. | |
| Cohort B: statin-nonuse | Not described Receives: Diagnostic Test: TOF (Train-of-Four) monitoring for depth of neuromuscular blockade. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach TOF count 0
time from administration of rocuronium to reach TOF count 0
Measured: 0th minute
Time to reach TOF 40
time to intraoperatively TOF reached 40
Measured: about 40th minute
Time to reach TOF 90 (reversal of neuromuscular blockade)
Measured postoperatively after sugammadex administration and additional doses if required.
Measured: about 60th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- Emine Emen, ass. Dr., Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834776
- Sponsor's protocol ID
- TABED 1-24-830
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06834776
- Acronym / sponsor ID
- TABED 1-24-830
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Cohort B: statin-nonuse, cohort A: statin-use |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine Emen, ass. Dr. study chair
Ankara City Hospital Bilkent
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Statin-Associated Myopathy, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ismail aytaç, assoc. Prof. Dr (+905056340369, aytacismail1972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach TOF count 0 (time frame: 0th minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.