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

JRCT ID: jRCTs021220016

Registered date:21/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cardiovascular diseases
• Date of first enrollment: 21/07/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 target sedation level.
Dexmedetomidine group: Dexmedetomidine is adjusted between 0.2 to 0.7 mcg/kg/hr to achieve target sedation level.

Outcome(s)

• Primary Outcome: 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 Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hakozaki Takahiro
• Source(s) of Monetary Support: japan society for the promotion of science