A randomized controlled comparison of total intravenous anaesthesia and balanced anaesthesia for interventional repair of mitral regurgitation: myocardial ischemia and haemodynamics.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004886

Enrollment

Registered

2013-04-17

Start date

2013-04-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I34.0 R11 F05.8 I24

Interventions

Group 1: Total intravenous anaesthesia (TIVA: Propofol + Remifentanil) for percutanuous correction of severe mitral regurgitation with the MitraClip-System. Group 2: Balanced anaesthesia (Desflurane +

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • age>18 years • informed consent for MitraClip® • informed consent for general anaesthesia • informed consent of anaesthesiologist

Exclusion criteria

Exclusion criteria: • age <18 years • missing informes consent • myocardial infarction during last 6 weeks before intervention • contraindications against Propofole, inhalative anaesthetics, Remifentanil, CisAtracurium • use of sulfonylurea, theophylline or allopurinol • history of inguinal vascular surgery

Design outcomes

Primary

Measure	Time frame
troponin I release 24 hours after induction of general anaesthesia	—

Secondary

Measure	Time frame
- myocardial infarction, defined as new Q-wave >= 40 ms in at least two corresponding leads or loss of R-wave in V1 to V6 or TnI >11,6 µg/l 24h post induction of general anaesthesia - changes in ST-segment during or after intervention - maximum decrease of cardiac output during intervention as measured with thermodilution method (PiCCO®) and with transesophageal echocardiography (TEE) immediately before and after induction of general anaesthesia, after 30 min, after mitral clipping and at the end of the procedure - maximum decrease in mid arterial pressure during intervention - accumulated time of hypotension defined as systolischer arterial pressure > -20% (compared to systolic blood pressure at time of assesment for anaesthesia) or mid arterial pressure (MAD) < 60 mmHg - accumulated dosage of vasopressors and/or ionotropes (noradrenalin, adrenalin, dobutamin) during intervention - conditions for intervention - duration of intervention - intensive care and hosptal length of stay (days) - incidence of post-interventional delirium	—

Measure

Time frame

- myocardial infarction, defined as new Q-wave >= 40 ms in at least two corresponding leads or loss of R-wave in V1 to V6 or TnI >11,6 µg/l 24h post induction of general anaesthesia - changes in ST-segment during or after intervention - maximum decrease of cardiac output during intervention as measured with thermodilution method (PiCCO®) and with transesophageal echocardiography (TEE) immediately before and after induction of general anaesthesia, after 30 min, after mitral clipping and at the end of the procedure - maximum decrease in mid arterial pressure during intervention - accumulated time of hypotension defined as systolischer arterial pressure > -20% (compared to systolic blood pressure at time of assesment for anaesthesia) or mid arterial pressure (MAD) < 60 mmHg - accumulated dosage of vasopressors and/or ionotropes (noradrenalin, adrenalin, dobutamin) during intervention - conditions for intervention - duration of intervention - intensive care and hosptal length of stay (days) - incidence of post-interventional delirium

—

Countries

Germany

Contacts

Public ContactJan Kügler

Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Charité - Campus Benjamin Franklin

jan.kuegler@charite.de030 - 8445 2733

Outcome results

None listed

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