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The impact of continuous ephedrine infusion vs. crystalloid solution infusion on cardiac index in patients during spinal anesthesia

The impact of continuous ephedrine infusion vs. crystalloid solution infusion on cardiac index in patients during spinal anesthesia - Cardiac index influenced by ephedrine vs. crystaloid infusions during spinal anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005704
Enrollment
60
Registered
2014-02-12
Start date
2014-04-07
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

Hypotension as the result of local anesthetic given intrathecally that caused vasodilation and drop of pressure. Syndrome of low cardiac output as the result of cardiomyopathy and impaired cardiac function and lower preload as the result of diuretic therapy and peripheral vasodilation. I95.2 I50.0

Interventions

Group 1: One group (30 patients) after intrathecal administration of local anesthetic gets infusion of crystaloids (Ringer solution) and Group 2: the other group (30 patients) gets vasoconstrictor

Sponsors

Department of anesthesiology, intensive care and pain medicine, General hospital Karlovac, Karlovac, Croatia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: The study will include patients from 45 to 75 years old, body mass index (18.5 to 35), male or female , anesthesiological risk ASA I , II or III. These will also be patients for elective orthopedic, trauma and vascular surgery of lower limbs.

Exclusion criteria

Exclusion criteria: Respondents must not have early malignancy of other organs, side effects to drugs and substances from the environment and operations that are longer than 60 minutes. The patients must not have any contraindications for intrathecal anesthesia. From the research will be excluded participants who will refuse cooperation at any stage of testing, or those that will have significant complications or side effects and the subjects in which will be indicated usage of blood products.

Design outcomes

Primary

MeasureTime frame
The primary goal of the research is to estimate the changes in these hemodynamic parameters (cardiac index-CI, stroke volume index-SVI, systemic vascular resistance index-SVRI and the amount of water in the lungs-TFC) after intrathecal administration of local anesthetic and monitoring changes in hemodynamic parameters every 10 minutes after administration of ephedrine or infusion of crystaloids such as Ringer solution. These parameters are monitored 5 minutes before spinal anesthesia and 3,5, 10 minutes after spinal anesthesia and every 10 minutes untill 60 min. after spinal anesthesia.

Secondary

MeasureTime frame
The secondary goal is to monitor is there any complications after spinal anesthesia such as headache, urinary retention, back pain. We will also monitor vital parameters such are: blood pressure, peripheral pulse, respiratory function, diuresis, laboratory parameters (red blood cells, white blood cells, creatinine, electrolytes).

Countries

Croatia

Contacts

Public ContactMatija Belavic

Department of Anesthesiology, intensive care and pain medicine, General Hospital Karlovac

matija.belavic@bolnica-karlovac.hr+38547608311

Outcome results

None listed

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