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Sedation with Esketamine and Dexmedetomidine in Patients Undergoing Transcatheter Aortic Valve Implantation

Sedation with Esketamine and Dexmedetomidine in Patients Undergoing Transcatheter Aortic Valve Implantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098048
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Anaesthesia for cardiac surgery

Interventions

dexmedetomidine group (group D):dexmedetomidine (0.5 µg/kg loading, 0.5 µg/kg/h infusion)
dexmedetomidine plus low-dose esketamine group (group DEl):dexmedetomidine (0.5 µg/kg loading, 0.3 µg/kg/h infusion) and esketamine (0.5 mg/kg loading, 5 µg/kg/min infusion)
dexmedetomidine plus high-dose esketamine group (group DEh ):dexmedetomidine (0.5 µg/kg loading, 0.3 µg/kg/h infusion) and esketamine (0.5 mg/kg loading, 10 µg/kg/min infusion)

Sponsors

Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients with severe symptomatic aortic valve stenosis; 2. age >=75 years; 3. at high risk for conventional surgical aortic valve replacement were eligible for enrolment (ie, logistic European System for Cardiac Operative Risk Evaluation >=20% or Society of Thoracic Surgeons risk score >=10% or other high risk criteria by heart team consensus); 4. suitability for transfemoral vascular access were also required.

Exclusion criteria

Exclusion criteria: 1. contraindication for a specific mode of anesthesia or the TAVR procedure; 2. clear patient specific clinical reasons to prefer one form of anesthesia over the other; 3. cardiogenic shock or hemodynamic instability; 4. history of or active endocarditis; 5. active infection requiring antibiotic treatment; 6. active peptic ulcer or upper gastrointestinal bleeding< 3 months; 7. hypersensitivity or contraindication to aspirin, heparin, or clopidogrel; 8. neurocognitive/neurodegenerative disease or psychiatric disorder, or using antidepressants/sedatives were excluded.; 9. and participation in another trial. Secondary exclusion criteria were perioperative emergency conversion from sedation to general anesthesia and the need for cardiopulmonary resuscitation during the study period.

Design outcomes

Primary

MeasureTime frame
Recovery -15 (QoR-15) score;Perioperative self-rated anxiety scale (SAS) score;Postoperative Insomnia Scale (AIS) score;Hospital Anxiety and Depression Scale (HADS) score;

Secondary

MeasureTime frame
Intraoperative BIS;Heart rate;Systolic and diastolic blood pressure;Wake time;Vasoactive and inotropic needs and doses;Sedation start time;Oxygen saturation;Length of hospital stay and pre-medication related adverse reactions;Mean Intensive Care Unit (ICU);Mean length of hospital stay;

Countries

China

Contacts

Public ContactZhang Liang

Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vascular Diseases

zhangliangyoyo27@sina.com+86 158 1059 0875

Outcome results

None listed

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