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

Effect of Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333145
• Other study ID #: EDRA
• Status: Recruiting
• Phase: Phase 4
• Start date: February 4, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: mujun chang
• Phone: +862783663625
• Email: changmujun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1. Age 18-65 years old, 2. ASA ?-? 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.

Related Conditions & MeSH terms

• Effect of Drug

Intervention

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

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

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