Skip to content

Effect of Esketamine Pretreatment on the ED95 of Remimazolam for Sedation Induction and Hemodynamic Stability in Elderly Patients: A Prospective, Randomized, Double-Blind, Sequential Dose-Finding Study

Effect of Esketamine Pretreatment on the ED95 of Remimazolam for Sedation Induction and Hemodynamic Stability in Elderly Patients: A Prospective, Randomized, Double-Blind, Sequential Dose-Finding Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124569
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Sedation for General Anesthesia in Elderly Patients

Interventions

R group:Remazolam induction sedation (sequential dose exploration)
R+E group:Esketamine pre-treatment + Remazolam induction sedation (sequential dose exploration)

Sponsors

General Hospital of the Eastern Theatre of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ASA physical status I–III; 2. Aged 60–80 years; 3. Body mass index (BMI) 18–30 kg/m^2; 4. Scheduled to undergo unilateral total knee arthroplasty under general anesthesia with endotracheal intubation.

Exclusion criteria

Exclusion criteria: 1. Known allergy or contraindication to benzodiazepines or esketamine; 2. Uncontrolled hypertension (defined as resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); 3. Severe psychiatric illness, severe liver or renal dysfunction; 4. Use of opioids, alcohol, benzodiazepines, or over-the-counter sleep aids; 5. Diagnosed dementia or severe cognitive impairment; 6. Refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
ED95 of remimazolam for successful induction sedation;

Secondary

MeasureTime frame
Incidence of hypotension during the initial induction observation window;Minimum MAP during the initial induction observation window;Maximum decrease in MAP during the initial induction observation window;Incidence of hypotension during the complete induction-to-intubation observation window;Rate of phenylephrine use;Hemodynamic parameters;

Countries

China

Contacts

Public ContactHui Kangli

General Hospital of the Eastern Theatre of the Chinese People's Liberation Army

m15951899306@163.com+86 159 5189 9306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026