The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To determine the effect of the opiate remifentanil and of the inhalative anaesthetics isoflurane (only part I), sevoflurane and desflurane on the diastolic function of the left ventricle in healthy young adults, and in patients with diastolic dysfunction
Study Overview
Brief Summary
Anaesthetics may impair the diastolic function of the heart, but the importance of this finding for patients has not been sufficiently examined. Specially the effects on diastolic function in patients with diastolic dysfunction has to be determined. The aim of this study is to examine the effect of isoflurane (only part I), sevoflurane and desflurane (part I+II) on the diastolic left ventricular function by doppler echocardiography.
Detailed Description
In part I, 60 healthy young subjects free from cardiovascular disease will be examined. In part II, 50 patients with impaired diastolic but preserved systolic function, i.e., patients with arterial hypertension and ejection fraction > 50%. Doppler echocardiography will be performed at baseline before induction of anaesthesia, during anaesthesia in the spontaneously breathing patient, and in the mechanically ventilated patient.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •part I: 18- to 50-year-old patients undergoing surgical procedures under general anesthesia
- •part II: 50-years-old patients or older with arterial hypertension under chronic antihypertensive medication subsequently undergoing surgical procedures under general anesthesia, EF >50%
Exclusion Criteria
- •part I: any cardiac or pulmonary disease, any medication with cardiovascular effects or side effects, body mass index > 30 kg/m2, esophageal reflux, emergency
- •part II: History of myocardial infarction or coronary revascularization, severe lung disease, body mass index > 30 kg/m2, esophageal reflux, emergency
Arms & Interventions
I
Isoflurane (only in part I)
Intervention: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl (Drug)
I
Isoflurane (only in part I)
Intervention: Sevoflurane, Isoflurane, Desflurane (Drug)
II
Sevoflurane
Intervention: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl (Drug)
II
Sevoflurane
Intervention: Sevoflurane, Isoflurane, Desflurane (Drug)
III
Desflurane
Intervention: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl (Drug)
III
Desflurane
Intervention: Sevoflurane, Isoflurane, Desflurane (Drug)
Outcomes
Primary Outcomes
To determine the effect of the opiate remifentanil and of the inhalative anaesthetics isoflurane (only part I), sevoflurane and desflurane on the diastolic function of the left ventricle in healthy young adults, and in patients with diastolic dysfunction
Secondary Outcomes
No secondary outcomes reported