A Study of Remimazolam Combined with Remifentanil in Elderly Patients Undergoing Short-Duration Urological Surgical Procedures

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500100517

Enrollment

Unknown

Registered

2025-04-10

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Ureterolithiasis

Interventions

Control group:Propofol Combined with Remifentanil for Anesthesia Induction and Maintenance

Experimental group:Remimazolam Combined with Remifentanil for Anesthesia Induction and Maintenance

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Inclusion criteria

Inclusion criteria: Proposed urological short surgery; Age >=65 years and =18kg/m² and <=28kg/m²; Agree to participate in this trial, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Those with a history of severe brain, heart, liver, lung, kidney and metabolic diseases; Patients with arrhythmias such as severe atrioventricular block, sinus bradycardia or sick sinus syndrome; Those who have uncontrolled hypertension (basal blood pressure systolic blood pressure > 180 mmHg and/or diastolic blood pressure >110 mmHg) before surgery, or who need to use vasoactive drugs to maintain blood pressure; Long-term use of narcotic analgesics and sedatives; Those with epilepsy, mental illness, or those who do not cooperate or are unable to communicate; Those who are known to be allergic to the drugs used in this experiment (such as benzodiazepines, propofol, opioids, cis-atracurium, etc.) or contraindicated to their use; Those who have a history of abnormal surgical anesthesia in the past.

Design outcomes

Primary

Measure	Time frame
Sedation Success Rate of Remimazolam;Induction Dose of Remimazolam;	—

Secondary

Measure	Time frame
Time from the Start of Anesthesia Induction to Achieving Bispectral index(BIS) <=60;Changes in Vital Signs: Heart Rate((HR),Mean Arterial Pressure((MAP), Peripheral Capillary Oxygen Saturation(SpO2), Bispectral Index(BIS);Cognitive Function Assessment (Mini-Mental State Examination,MMSE);Postoperative 24-Hour Recovery Quality Assessment :Quality of Recovery-15 (QoR-15);Stress Response Biomarkers :Adrenocorticotropic Hormone (ACTH), Cortisol(Cor), Norepinephrine(NE);Serum Inflammatory Cytokine Levels :C-Reactive Protein(CRP), Tumor Necrosis Factor-alpha(TNF-a),Interleukin-6( IL-6);Wake time;Extubation time;	—

Measure

Time frame

Time from the Start of Anesthesia Induction to Achieving Bispectral index(BIS) <=60;Changes in Vital Signs: Heart Rate((HR),Mean Arterial Pressure((MAP), Peripheral Capillary Oxygen Saturation(SpO2), Bispectral Index(BIS);Cognitive Function Assessment (Mini-Mental State Examination,MMSE);Postoperative 24-Hour Recovery Quality Assessment :Quality of Recovery-15 (QoR-15);Stress Response Biomarkers :Adrenocorticotropic Hormone (ACTH), Cortisol(Cor), Norepinephrine(NE);Serum Inflammatory Cytokine Levels :C-Reactive Protein(CRP), Tumor Necrosis Factor-alpha(TNF-a),Interleukin-6( IL-6);Wake time;Extubation time;

—

Countries

China

Contacts

Public ContactYuanhua Li

The First Affiliated Hospital of Kunming Medical University

blue_sunny220@163.com+86 137 0873 6113

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026