ED50 of Remimazolam for Anesthesia Induction in Frail Elderly Patients

NCT07467603 | Completed

• 1 other identifier: 2025-R031
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the median effective dose (ED50) of remimazolam for loss of consciousness (LOC) in elderly and frail elderly patients using the Dixon up-and-down method, while utilizing a novel Respiratory Volume Monitor (RVM) to detect subclinical respiratory depression.

Conditions

Frailty; Anesthesia Induction

Keywords

Remimazolam Tosilate; Frailty; Anesthesia Induction; Median Effective Dose (ED50); Dixon Up-and-Down Method; Respiratory Volume Monitor (RVM)

Outcome Measures

Primary Outcomes (1)

• Sedation Success (Loss of Consciousness)

  Defined as the achievement of Loss of Consciousness (LOC) confirmed by loss of eyelash reflex, no response to verbal commands, Ramsay Sedation Score ≥ 5, and MOAA/S score \< 1.

  up to 2 minutes

Secondary Outcomes (4)

• Median Effective Dose (ED50) of Remimazolam

  Perioperative/Periprocedural

• Changes in Tidal Volume (VT)

  Baseline, 30 seconds, 60 seconds, 90 seconds, and up to 120 seconds post-administration

• Mean Arterial Pressure (MAP)

  Baseline and up to 2 minutes post-administration

• Heart Rate (HR)

  Baseline and up to 2 minutes post-administration

Study Arms (2)

Elderly Group (Non-Frail)

EXPERIMENTAL

Patients with a Clinical Frailty Scale (CFS) score \< 5.

Drug: Remimazolam Tosilate

Frail Elderly Group

EXPERIMENTAL

Patients with a Clinical Frailty Scale (CFS) score ≥ 5.

Drug: Remimazolam Tosilate

Interventions

Remimazolam Tosilate DRUG

The initial induction dose was set at 0.15 mg/kg administered as a single intravenous bolus over 30 seconds. The dose adjustment gradient for consecutive patients was 0.02 mg/kg based on the Dixon up-and-down method.

Elderly Group (Non-Frail)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged ≥65 years;
• Scheduled for elective surgery under general anesthesia with endotracheal intubation;
• American Society of Anesthesiologists (ASA) physical status II or III;
• Body Mass Index (BMI) between 18 and 30 kg/m².

You may not qualify if:

• Known allergy to benzodiazepines;
• History of severe respiratory or cardiovascular disease (e.g., acute heart failure, severe COPD);
• Long-term use of sedatives, analgesics, or alcohol abuse;
• Known neuromuscular disorders (e.g., myasthenia gravis);
• Inability to communicate for sedation assessment.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 12, 2026
• Study Start: February 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (1)