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Remimazolam requirement for insertion of supraglottic airway device(I-gel) without NMB : a Dose-finding study using Dixon up-and-down method

Remimazolam requirement for insertion of supraglottic airway device(I-gel) without NMB : a Dose-finding study using Dixon up-and-down method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006527
Enrollment
44
Registered
2021-09-01
Start date
2021-11-11
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients under 65 years of age with ASA class I or II 2) Patients undergoing hysteroscopy under general anesthesia

Exclusion criteria

Exclusion criteria: 1) Children (under 18 years old) 2) BMI>30kg/m2 or <18.5kg/m2 3) People with severe liver disease 4) Neuromuscular disease or mental illness 5) metabolic disease 6) drug or alcohol addiction 7) Emergency surgery 8) Pregnant women, lactating women 9) Those who are contraindicated in benzodiazepine drugs and sevoflurane (e.g., patients who are allergic to drugs or have a history of hypersensitivity reactions) 10) Patients with acute narrow-angle glaucoma 11) Patients in shock or coma 12) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption 13) Patients with severe hypersensitivity to dextran 40 14) If patient's anesthesiologist refuses to use remimazolam 15) Patients with sleep apnea syndrome 16) Patients with severe or acute respiratory failure

Design outcomes

Primary

MeasureTime frame
LMA insertion success (success: loss of consciousness and Muzi score of 2 or less at LMA insertion)

Secondary

MeasureTime frame
Blood pressure;Heart rate;adverse effects (Tachycardia, bradycardia, hypertension, hypotension, hypoventilation, decrease of SpO2);Time to loss of consciousness after injection of Remimazolam;Total remimazolam dose;Whether arousal or recall during surgery (using Modified Brice questionnaire);Duration of apnea;Nausea, Vomiting

Countries

Korea, Republic of

Contacts

Public ContactJoan Seungwon Lee

Samsung Medical Center

seungwon0209.lee@samsung.com+82-2-3410-0369

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 12, 2026