Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam.
- Who it may be relevant to
- Registry conditions: Emergence Agitation, General Anesthesia, Nasal Surgical Procedures. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery Under Sevoflurane Anesthesia: A Randomized Double-blind Non-inferiority Trial
Overview
Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression. This randomized, double-blind, non-inferiority trial will compare low-dose remimazolam (0.03 mg/kg) with the standard dose (0.1 mg/kg) administered at the end of surgery in adult patients undergoing nasal surgery under sevoflurane anesthesia. The primary objective is to determine whether low-dose remimazolam is non-inferior to the standard dose in preventing emergence agitation. Secondary outcomes include burst suppression, recovery profiles, and safety outcomes.
Detailed description
Emergence agitation (EA) is characterized by confusion, agitation, and non-purposeful movements during recovery from general anesthesia. In adult patients undergoing nasal surgery with sevoflurane anesthesia, EA occurs frequently and may result in self-injury, accidental removal of medical devices, postoperative bleeding, prolonged recovery, and increased healthcare burden.
Remimazolam is an ultra-short-acting benzodiazepine that is rapidly metabolized by tissue esterases and can be antagonized with flumazenil. Previous studies have demonstrated that intravenous administration of remimazolam 0.1 mg/kg at the end of surgery reduces the incidence of EA after nasal surgery. However, this dose may produce deeper-than-necessary sedation and increase the occurrence of burst suppression, which has been associated with postoperative delirium.
The present study aims to evaluate whether a lower dose of remimazolam (0.03 mg/kg), corresponding to the supplemental dose commonly used for procedural sedation, can preserve the preventive effect on EA while reducing excessive electroencephalographic suppression and improving recovery characteristics.
This is a prospective, randomized, double-blind, non-inferiority trial conducted at Jeju National University Hospital. Adult patients scheduled for nasal surgery under sevoflurane anesthesia will be randomly assigned in a 1:1 ratio to receive either remimazolam 0.03 mg/kg or remimazolam 0.1 mg/kg immediately after discontinuation of sevoflurane at the end of surgery.
The primary outcome is the incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater. Secondary outcomes include the incidence and duration of burst suppression assessed using the SedLine monitor, Patient State Index (PSi), extubation time, post-anesthesia care unit (PACU) length of stay, and safety outcomes including hypoxemia, hypotension, flumazenil administration, and other adverse events.
Interventions
- Drug Remimazolam
Remimazolam will be administered intravenously immediately after discontinuation of sevoflurane at the end of surgery. Participants will receive either 0.03 mg/kg or 0.1 mg/kg according to randomized treatment allocation.
Primary outcome measures
- Incidence of emergence agitation [Time frame: Within 15 minutes after extubation]
Secondary outcome measures (3)
- Incidence of burst suppression [Time frame: From study drug administration until extubation(up to 30 minutes)]
- Duration of burst suppression [Time frame: From study drug administration until extubation(up to 30 minutes)]
- Lowest Patient State Index (PSI) [Time frame: From study drug administration until extubation(up to 30 minutes)]
Eligibility criteria
Inclusion criteria
- Adults aged 18 to 79 years.
- Scheduled to undergo elective nasal surgery under sevoflurane-based general anesthesia at Jeju National University Hospital.
- Able to provide written informed consent.
Exclusion criteria
- Contraindications to remimazolam.
- History of allergy or hypersensitivity to benzodiazepines.
- Inability to provide informed consent due to cognitive impairment.
- Preexisting psychiatric disorders.
- History of alcohol or substance abuse.
- Inability to assess the Riker Sedation-Agitation Scale (SAS).
- Body mass index (BMI) > 40 kg/m².
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Jeju National University Hospital — Jeju City
Identifiers
NCT: NCT07740655 · JEJUNUH 2026-06-005-001