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

Phase 4RecruitingNCT06333145

Tongji Hospital165 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Effect of Drug

Interventions

RemimazolamDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Ramsey Sedation Scale

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.

Time frame: 1 day

Secondary Outcomes

Time records

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

Time frame: 1 day

Use of drugs

The total amount of sedative and analgesic drugs used.

Time frame: 1 day

Respiratory suppression incidence

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

Time frame: 1 day

Incidence of Treatment-Emergent Adverse Events

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.

Time frame: 2 days

Incidence of PACU Adverse Reactions

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

Time frame: 1 day

Central Contacts

mujun chang

CONTACT

+862783663625 changmujun@hotmail.com

Data from ClinicalTrials.gov

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