Kinetics of the hemodynamic effects of Cafedrine/Theodrenalin (Akrinor®) in hypotension under general anesthesia (TIVA) and spinal anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017132

Enrollment

120

Registered

2019-05-10

Start date

2019-04-11

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

The hemodynamic effect of akrinor (cafedrin/ theodrenalin) in hypotension during initiation of general anaesthesia or application of spinal anaesthesia

Interventions

Group 1: General anaesthesia (TIVA): The study population consists exclusively of adult patients who receive general anesthesia and non-invasive continuous blood pressure measurement during surgery.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Risk group ASA I-III Age >18 years Spinal anaesthesia or general anaesthesia (TIVA) Planned continuous hemodynamic monitoring using volume clamp technology

Exclusion criteria

Exclusion criteria: Risk group ASA IV-VI Significantly reduced left ventricular pump function (EF<40 %) / NYHA=III Known intolerance to cafedrin/ theodrenalin (Akrinor®) Contraindications (mitral stenosis, narrow-angle glaucoma, untreated hyperthyroidism, pheochromocytoma) stated in the specialist information Cafedrin/theodrenalin (Akrinor®) Cardiac surgery caesarean section Possible ACE inhibitor medication not paused on operation day Insufficient perfusion of the upper extremities that interfere with the volume clamp technique

Design outcomes

Primary

Measure	Time frame
1. What is the progression over the time of the different hemodynamic effects (MAP, HZV/ SV, SVR, PPV) of the drug combination cafedrine/theodrenalin (Akrinor®) in hypotension during anaesthetic induction? 2. Are there differences in pharmacodynamics between spinal and general anesthesia (TIVA)? The endpoints are measured by non-invasive continuous blood pressure measurement (Clearsight® System, EV 1000 Clinical Platform, Edwards Lifesciences Services GmbH) every 20 seconds for 30 minutes after the last Akrinor application.	—

Measure

Time frame

1. What is the progression over the time of the different hemodynamic effects (MAP, HZV/ SV, SVR, PPV) of the drug combination cafedrine/theodrenalin (Akrinor®) in hypotension during anaesthetic induction? 2. Are there differences in pharmacodynamics between spinal and general anesthesia (TIVA)? The endpoints are measured by non-invasive continuous blood pressure measurement (Clearsight® System, EV 1000 Clinical Platform, Edwards Lifesciences Services GmbH) every 20 seconds for 30 minutes after the last Akrinor application.

—

Secondary

Measure	Time frame
1. Does the hemodynamic effect of cafedrin/theodrenalin (Akrinor®) in patients who regularly take beta-blockers differ from that of beta-blocker-naïve patients? 2. Does the pharmacodynamic effect of cafedrin/theodrenalin (Akrinor®) in a possible second injection in recurrent hypotension (within 15 min) differ from the hemodynamic effect spectrum in first injection? 3. What is the time course of pulse rate after cafedrin/theodrenalin (Akrinor®) administration depending on the anaesthetic procedure? 4. Are there gender-specific differences in pharmacodynamics? 5. What time latency exists after caf/theo application until the relative increase of the MAP by 10 % or until the MAP rises above 65 mmHg (clinically relevant limit values)	—

Measure

Time frame

1. Does the hemodynamic effect of cafedrin/theodrenalin (Akrinor®) in patients who regularly take beta-blockers differ from that of beta-blocker-naïve patients? 2. Does the pharmacodynamic effect of cafedrin/theodrenalin (Akrinor®) in a possible second injection in recurrent hypotension (within 15 min) differ from the hemodynamic effect spectrum in first injection? 3. What is the time course of pulse rate after cafedrin/theodrenalin (Akrinor®) administration depending on the anaesthetic procedure? 4. Are there gender-specific differences in pharmacodynamics? 5. What time latency exists after caf/theo application until the relative increase of the MAP by 10 % or until the MAP rises above 65 mmHg (clinically relevant limit values)

—

Countries

Germany

Contacts

Public ContactJulika Weyland

Klinik für Anästhesiologie/Intensivmedizin/Notfallmedizin/ SchmerztherapieKlinikum Oldenburg AöR

weyland.julika@klinikum-oldenburg.de04414032571

Outcome results

None listed

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