Skip to content

A Randomized Controlled Trial to Compare The Sedative Efficacy and Safety of Isoflurane and Dexmedemomidine in Patients after Cardiovascular Surgery

A Randomized Controlled Trial to Compare The Sedative Efficacy and Safety of Isoflurane and Dexmedetomidine in Patients after Cardiovascular Surgery - ANACOMDA study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021220016
Enrollment
60
Registered
2022-07-21
Start date
2023-04-25
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

cardiovascular diseases Cardiovascular surgery

Interventions

Isoflurane group: Isoflurane infusion starts 3 ml/hr to Anesthetic Conserving Device. Isoflurane infusion is adjusted between 0 to 7 ml/hr, end tidal isoflurane concentration 0 to 1 % to achieve targe

Sponsors

Hakozaki Takahiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained from the patient 2. Patirnt over 18 years at the time of imformed consent 3. patient undergoing scheduled cardiovasclar surgery 4. patient who are schedulled to receive mechanical ventilation after surgery 5. Ventilatory weaning expected in more than 2 hours but less than 48 hours 6. Patient who are not receiving mechamical cirulatory support 7. Patient who are not receiving renal replacement therapy

Exclusion criteria

Exclusion criteria: 1. Patient with history of malignant hyperthermia or a family history of malignant hyperthremia 2. Diagnosed moderate chronic respitatory failure 3. Diagnosed moderate chronic heart failure 4. Diagnosed moderate chronic kidney disease 5. Patient who are receiving or schedulled to receive mechanical circulatory support 6. Patient judged to be inappropriate for inclusion

Design outcomes

Primary

MeasureTime frame
Geometric mean of the percentage of eccessive mean tidal volume (over 8 ml/kg PBW) every 5 minutes during the first 2 hours after sedation.

Secondary

MeasureTime frame
Number of ventilator setting adjustments, asynchrony rate, time not achieving target sedation level, duration of ventilation, cumulative opioid dose, cumulative cathecholamine dose, troponin I change rate, presence of delirium, acute kidney injury, P/F ratio change rate, liver injury, nausea/vomiting, ICU stay, 28-day mortality

Contacts

Public ContactTakahiro hakozaki

Fukusima Medical University Hospital

hakota93@fmu.ac.jp+81-24-547-1342

Outcome results

None listed

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