Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
NCT Number: NCT07675850
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.
The main questions it aims to answer are:
Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?
Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?
Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.
Participants will:
* Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen. * Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor. * Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).
Trial opening soon.
Get Notified19 year–79 year
All sexes
Interventional
Phase 4
Seoul, Jongno-gu, 03080, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eleveld model-guided dosing via a validated web-based calculator
Induction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h
Time frame: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h
Time frame: Time from the start of remimazolam administration to loss of consciousness (min), up to 1h
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Ephedrine (mg)
Time frame: Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h
Time frame: From discontinuation of remimazolam to patient discharge from the operating room, up to 1h
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural, on the day of surgery
Time frame: Perioperative/Periprocedural, up to 1 week
Time frame: Perioperative/Periprocedural, up to 1 week
Time frame: Perioperative/Periprocedural, on the day of surgery
Time frame: Perioperative/Periprocedural, on the day of surgery
Drop in the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score to 3 or lower during the PACU stay
Time frame: Perioperative/Periprocedural
assessed using the Modified Brice Questionnaire
Time frame: Perioperative/Periprocedural
phenylephrine (㎍)
Time frame: Perioperative/Periprocedural
norepinephrine (㎍)
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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