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Completed

NCT Number: NCT06333145

ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults

Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.

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Key information

Conditions

Effect of Drug

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep Endoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.

Exclusion criteria

  • 1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.

Treatment and study plan

Remimazolam

Drug

Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy

Other names: Remimazolam besylate

Primary outcomes

  1. Ramsey Sedation Scale

    Time frame: 1 day

    Using the Ramsey Sedation Scale scoring table ranging from 1-6 to evaluate if the sedation is successful

    1point: Patients are anxious, restless or irritable; 2point: Patients cooperative, well-oriented and quiet; 3point: Patients fall asleep and respond only to commands; 4point: Patients fall asleep and respond quickly to eyebrow taps or loud auditory stimuli; 5point: Patients fall asleep and are blunt to respond to eyebrow taps or loud auditory stimuli; 6point: Patients fall asleep and do not respond to the above stimuli.

Secondary outcomes

  1. Time records

    Time frame: 1 day

    Anesthesia time, induction time, surgical time, awakening time and recovery time

  2. Use of drugs

    Time frame: 1 day

    The total amount of sedative and analgesic drugs used.

  3. Respiratory suppression incidence

    Time frame: 1 day

    Respiratory frequency<8 times/min or SP02<90%

  4. Incidence of Treatment-Emergent Adverse Events

    Time frame: 2 days

    Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc.

  5. Incidence of PACU Adverse Reactions

    Time frame: 1 day

    Nausea and vomiting, pain (VAS score), hypotension, bradycardia, dizziness;

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Jul 1, 2026

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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