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

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

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

Study Overview

• Status: Recruiting
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: Remimazolam

Detailed Description

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
• Enrollment (Estimated): 165
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: mujun chang; Phone Number: +862783663625; Email: changmujun@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital
      • Contact: aijun xu, Dr.; Phone Number: 027-83663173; Email: ajxu@tjh.tjmu.edu.cn
      • Contact: yuan Bi, Dr.; Phone Number: 027-18972718216; Email: 18972718216@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: normal group; BMI: ≥18.5 and <24	Drug: Remimazolam; Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy; Other Names: Remimazolam besylate
Experimental: overweight group; BMI: ≥24 and <30	Drug: Remimazolam; Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy; Other Names: Remimazolam besylate
Experimental: obese group; BMI: ≥30	Drug: Remimazolam; Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy; Other Names: Remimazolam besylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory suppression incidence	Respiratory frequency<8 times/min or SP02<90%	1 day
Use of drugs	The total amount of sedative and analgesic drugs used.	1 day
Time records	Anesthesia time, induction time, surgical time, awakening time and recovery time	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.	2 days
Incidence of PACU Adverse Reactions	Nausea and vomiting, pain (VAS score), hypotension, bradycardia, dizziness;	1 day

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: Aihua Du, Dr, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: remimazolam; ED90; Drug-induced Sleep Endoscopy
• Other Study ID Numbers: EDRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: You can request it from the main researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No