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AdultNCT05841667

Impact of CES1 Genotype on Remimazolam

An observational study of Adult and Middle Aged, run by Korea University Guro Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Remimazolam is primarily metabolized via CES1, and other drugs that are commonly metabolized by CES1 are known to have their pharmacokinetics and clinical effects affected by genetic polymorphisms in CES1. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Adult, Middle Aged, Elective Surgical Procedures
What is being tested?
Remimazolam besylate
How many people
120 participants
Where
1 siteSouth Korea
Study dates
6 Sep 2023to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will be conducted on adult patients aged 19-70 years, ASA physical status 1-2, undergoing elective surgery in the operating room of Korea University Guro Hospital.

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status 1 or 2
  • Age 19-70 years
  • Elective surgery

Who cannot join

  • Concomitant regional anesthesia
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg)
  • Uncontrolled diabetes mellitus (HbA1c >9.0%)
  • Aspartate transaminase (AST), Alanine transferase (ALT), Total bilirubin > more than 2 times the normal upper limit
  • Estimated glomerular filtration rate <60 ml/min/1.73m2
  • Moderate to severe chronic pulmonary obstructive disease or respiratory failure
Show all 22Show fewer
  • Emergency
  • Hepatectomy, Liver transplantation
  • Cardiopulmonary bypass use
  • Craniotomy due to head trauma, unstable intracranial pressure, or brain disease
  • Use of benzodiazepine medications (if tolerance is present)
  • Anxiety, alcohol/drug dependence, or addiction to tricyclic antidepressants
  • Reported hypersensitivity and adverse reactions to benzodiazepines, flumazenil, and other agents used during anesthesia
  • Lactose-related genetic disorders
  • Myasthenia gravis or myasthenia gravis syndrome
  • Newly diagnosed myocardial infarction/clinically significant coronary artery disease, cerebral ischemic attack/stroke within 6 months, or significant untreated coronary artery disease
  • Implanted rate-responsive cardiac pacemaker with a bioelectrical impedance sensor.
  • Intrinsic brain disorders or other conditions that make it difficult to determine the depth of anesthesia through EEG measurements (e.g., epilepsy)
  • History of severe allergies
  • Cognitive impairment that prevents comprehension of the instructions and consent form of this study, in case of sedation
  • Expected intraoperative blood loss of 1000 ml or more
  • Judged by the investigator to be unsuitable for participation in this study due to other reasons

Trial locations and contacts

1 site in 1 country.

Byung Gun Lim, MD, PhD contact

82-2-2626-1437

bglim9205@korea.ac.kr

Hye Bin Kim, MD, PhD contact

82-10-9183-5617

aneshbkim@gmail.com

South Korea1 site, 1 recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Hye Bin Kim, MD, PhD, 821091835617, anesbhkim@gmail.com

    Byung Gun Lim, MD, PhD, 821038289205, bglim9205@korea.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Clinical Study to Explore the Effect of Carboxylesterase 1 (CES1) Genotype on Pharmacokinetics, Safety, and Efficacy of Remimazolam

Remimazolam is primarily metabolized via CES1, and other drugs that are commonly metabolized by CES1 are known to have their pharmacokinetics and clinical effects affected by genetic polymorphisms in CES1.

The goal of this observational study is to investigate the impact of the CES1 genotype on the pharmacokinetics, safety, and efficacy of remimazolam in patients undergoing elective surgery.

Being tested
Remimazolam besylate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remimazolam besylateDrug

    This is an observational study, meaning that no interventions are actually administered to the participants. However, blood and urine samples will be collected for research purposes.

    Participants will receive remimazolam besylate for at least 2 hours during anesthesia and surgery. Blood will be drawn to determine the concentration of remimazolam in the blood at the following time points: (1) before remimazolam administration, (2) after remimazolam administration has lasted at least 2 hours without a change in concentration, (3) immediately before discontinuation of remimazolam if there has been a change in concentration since the second blood draw, (4) within 5 minutes of discontinuation, (5) within 15-60 minutes of discontinuation, and (6) 90 minutes after discontinuation. Urine will also be collected after the end of anesthesia to check for metabolites of remimazolam.

Study groups in NCT05841667
Study groupRoleWhat they receive
CES1 without or without single nucleotide polymorphism (SNP)We will determine the CES1 genotype of participants through a laboratory test. Several different types of SNPs can be identified, and analyses can be further stratified by CES1 SNP type.
Receives: Drug: Remimazolam besylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-adjusted steady-state concentration of remimazolam

    Determine the dose-adjusted steady-state concentration of remimazolam using Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS)

    Measured: Immediately before the initiation of remimazolam administration ~ 120 minutes after the cessation of remimazolam

  2. Maintenance dose of remimazolam for maintaining general anesthesia

    Hourly maintenance dose of remimazolam for maintaining general anesthesia

    Measured: Immediately before the initiation of remimazolam administration ~ 120 minutes after the cessation of remimazolam

  3. Total dose of remimazolam used to induce general anesthesia

    Determine the total dose of remimazolam to achieve loss of consciousness (LOC). Modified Observer's Alertness/Sedation Scale (MOAA/S) <2 indicates LOC. The MOAA/S scale assesses a patient's level of alertness and response to stimulation, and is scored on a 6-point scale (6: awake and alert, 1: deeply asleep and unresponsive to any stimulus).

    Measured: Initiation of remimazolam administration ~ 5 minutes after start of remimazolam

Secondary outcomes (22)

  1. Time to LOC after remimazolam administration during anesthesia induction

    Determine the time to achieve LOC after remimazolam dosing.

    Measured: Initiation of remimazolam administration ~ 5 minutes after start of remimazolam

  2. Time to bispectral index(BIS) < 60 after remimazolam administration during anesthesia induction

    Determine the time to achieve BIS <60 after remimazolam dosing

    Measured: Initiation of remimazolam administration ~ 10 minutes after start of remimazolam

  3. Changes in BIS during induction and maintenance of anesthesia

    Measure BIS during anesthesia

    Measured: Initiation of remimazolam administration ~ 30 minutes after cessation of remimazolam

  4. Percentage maintained BIS >60 during general anesthesia

    Calculate "Time maintained BIS >60 / Time remimazolam administered"

    Measured: Initiation of remimazolam administration ~ Cessation of remimazolam(up to 10 hours after start of remimazolam administration)

  5. Changes in BIS during anesthesia induction and maintenance

    Assess BIS values during general anesthesia

    Measured: Initiation of remimazolam administration ~ 30 minutes after cessation of remimazolam

  6. Postanesthesia care unit (PACU) length of stay

    Determine how long participants stay in the PACU before being transferred to a general ward

    Measured: PACU admission ~ PACU discharge (within 3 hours after PACU admission)

  7. Emergence delirium

    Richmond Agitation Sedation Scale (RASS) ≥1 indicates emergence delirium (RASS score ranges from -5 to +4, with negative numbers indicating varying degrees of sedation or lethargy, and positive numbers indicating varying degrees of agitation or restlessness)

    Measured: Immediately after extubation ~ 3 hours after PACU admission

  8. Resedation

    Richmond Agitation Sedation Scale (RASS) ≤-2 indicates resedation

    Measured: Immediately after extubation ~ 3 hours after PACU admission

  9. Precipitation

    Visually determine whether remimazolam administration causes precipitation in the fluid line through which the agent is administered

    Measured: Initiation of remimazolam administration ~ 10 minutes after start of remimazolam

  10. Injection pain caused by remimazolam administration

    Question the patient to determine if pain occurs at the intravenous site where remimazolam is administered (check only if it occurs)

    Measured: Initiation of remimazolam administration ~ 3 minutes after start of remimazolam

  11. Adverse events up to 48 hours after surgery

    All adverse events including nausea/vomiting, hypertension/hypotension(30% or more change in preoperative blood pressure), bradycardia (heart rate <50 beats per minute[bpm]), tachycardia (heart rate >100 bpm)

    Measured: Initiation of remimazolam administration ~ 48 hours after surgery

  12. Endogenous metabolites that occur as remimazolam is metabolized in the body (This is an exploratory check, meaning we do not know in advance what substances will be found)

    Analyze collected blood and urine to determine the metabolites of remimazolam (Therefore, various laboratory methods can be used to detect endogenous metabolites, but it is not known in advance exactly how)

    Measured: Immediately before the start of remimazolam ~ 120 minutes after remimazolam cessation

  13. Total dose of remimazolam during general anesthesia

    Determine the total dose of remimazolam during general anesthesia

    Measured: Initiation of remimazolam administration ~ Cessation of remimazolam(up to 10 hours after start of remimazolam administration)

  14. Total dose of remifentanil during general anesthesia

    Determine the total dose of remifentanil during general anesthesia

    Measured: Initiation of remifentanil administration ~ Cessation of remifentanil(up to 10 hours after start of remifentanil administration)

  15. Operation time

    Determine how long the surgery was performed

    Measured: Start of surgery ~ End of surgery(up to 10 hours after start of surgery)

  16. Anesthesia time

    Determine how long the general anesthesia was performed

    Measured: Initiation of remimazolam administration ~ Exit to the PACU (within 30 minutes after remimazolam cessation)

  17. Flumazenil dosage

    If the participants are not awake within 10 minutes after discontinuation of remimazolam, administer flumazenil and verify the total dosage (max: 1 mg).

    Measured: Cessation of remimazolam ~ 30 minutes after remimazolam cessation

  18. Pain score in PACU

    If the participants are able to verbalize their pain, use a Numerical Rating Scale (NRS), otherwise use a Visual Analog Scale (VAS). Both scales are used to measure pain intensity on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.

    Measured: PACU admission ~ PACU discharge (within 3 hours after PACU admission)

  19. Analgesic usage in PACU

    Identify the type and dose of opioid or non-opioid pain medication used to control the participants' pain.

    Measured: PACU admission ~ PACU discharge (within 3 hours after PACU admission)

  20. Delirium

    Determine delirium during post-operative hospitalization through electronic medical records

    Measured: After surgery ~ Hospital discharge (within 1 month after surgery)

  21. Postoperative complications

    Identify any complications during post-operative hospitalization through electronic medical records

    Measured: After surgery ~ Hospital discharge (within 1 month after surgery)

  22. Hospital stay after surgery

    Identify the hospital length of stay after surgery

    Measured: The day of surgery ~ Hospital discharge (within 1 month after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start6 Sep 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05841667
Sponsor's protocol ID
2023GR0069
Status last verified
Oct 2024
First submitted
10 Apr 2023
Last updated
15 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Adult and Middle Aged, run by Korea University Guro Hospital at 1 site in South Korea.

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 3 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Byung Gun Lim, MD, PhD (82-2-2626-1437, bglim9205@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-adjusted steady-state concentration of remimazolam (time frame: Immediately before the initiation of remimazolam administration ~ 120 minutes after the cessation of remimazolam). 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?

On the ClinicalTrials.gov record for NCT05841667.

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 15 Oct 2024.

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