Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery
For patients and families
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 with Flumazenil, Propofol.
- Who it may be relevant to
- Registry conditions: Emergence Agitation. Basic parameters: from 19 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
- Center list to be confirmed — check the primary protocol.
- 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
Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
Overview
Participants will be randomly assigned to receive general anesthesia with either remimazolaml-based total intravenous anesthesia reversed with flumazenil or propofol-based total intravenous anesthesia. The primary outcome is the incidence of emergence agitation evaluated at the time of awakening after surgery. Additional outcomes include time to extubation, hemodynamic stability, airway complications such as coughing or laryngospasm, and postoperative recovery profiles including pain, nausea, vomiting, and sedation in the post-anesthesia care unit. This study aims to determine whether remimazolam with flumazenil provides smoother emergence compared with propofol in patients undergoing nasal surgery.
Interventions
- Drug Remimazolam with Flumazenil
General anesthesia is induced and maintained with remimazolam (initial infusion approximately 6 mg/kg/hr for induction, then 1-2 mg/kg/hr for maintenance), along with remifentanil for analgesia. At the end of surgery, flumazenil is administered to reverse the sedative effect, starting with 0.2 mg IV, followed by 0.1 mg incremental doses every 1 minute as needed, up to a total dose of 1.0 mg. - Drug Propofol
General anesthesia is induced and maintained with propofol using target-controlled infusion (effect-site concentration up to 4.0 μg/mL), along with remifentanil for analgesia.
Primary outcome measures
- Incidence of Emergence Agitation [Time frame: From discontinuation of anesthesia to exit in the operating room]
Secondary outcome measures (3)
- Time to Tracheal Extubation [Time frame: From anesthesia discontinuation to extubation in the operating room]
- Intraoperative Hemodynamic Stability [Time frame: During anesthesia]
- Incidence of Airway Complications During Emergence [Time frame: during anesthesia]
Eligibility criteria
Inclusion criteria
\- Adults aged 19 years or older scheduled to undergo nasal surgery requiring general anesthesia
Exclusion criteria
- Declines or is unable to provide informed consent
- Body mass index (BMI) ≥ 30 kg/m²
- Pre-existing neurological or cognitive impairment
- Known contraindication or allergy to remimazolam, propofol, or flumazenil
- Any condition judged by the investigator to make participation inappropriate (e.g., unstable medical status, severe comorbidities)
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
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07265050 · 2507-174-1661