Comparison of the efficacy of ephedrine versus norepinephrine in the treatment of hypotension occurring after induction of general anesthesia in patients with chronic renal failure.

Phase 1

• Conditions: Hypotension occurring post-induction of general anesthesia in patients with chronic renal failure during elective surgery.; MedDRA version: 21.1Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857; MedDRA version: 20.0Level: PTClassification code 10021097Term: HypotensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2022-002892-12-BE
• Lead Sponsor: CHU Brugmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-18
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 18 and 75 years old
Signed informed consent
Elective, non-cardiac surgery
General anaesthesia
Chronic renal failure with a GFR less than 45ml/min/m2 (stages below grade 3b and chronically on dialysis).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Congestive heart failure with LVEF < 50%
Moderate or severe cardiomyopathy or valvulopathy
History of atrial or ventricular arrhythmia
Taking drugs from the class of ACE inhibitors and sartans <24 hours before anesthesia
Chronic treatment with central antihypertensives such as a2 agonists
Chronic treatment with antidepressants of the following classes: selective norepinephrine reuptake inhibitors, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors, norepinephrine and dopamine reuptake inhibitors, monoamine oxidase inhibitors.
BMI <18.5kg/m2 or >35kg/m2
ASA score = 4
Pregnant women
Allergy to a product used for anesthesia
Prone position required during surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified