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.

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: randomized double-blind pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002892-12-BE

Enrollment

Registered

2022-08-18

Start date

2022-09-13

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Hypotension occurring post-induction of general anesthesia in patients with chronic renal failure during elective surgery. MedDRA version: 21.1 Level: LLT Classification code 10009119 Term: Chronic renal failure System Organ Class: 100000004857 MedDRA version: 20.0 Level: PT Classification code 10021097 Term: Hypotension System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Éphédrine HCL Aguettant Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ephedrine hydrochloride CAS Number: 50-98-6 Other descriptive name: Ephedrine

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Congestive heart failure with LVEF 35kg/m2 ASA score = 4 Pregnant women Allergy to a product used for anesthesia Prone position required during surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main aim of this study is to compare the efficacy of ephedrine versus norepinephrine in the treatment of hypotension occurring after induction of general anesthesia in patients with chronic renal failure during elective surgery.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint: the difference in the number of vasopressor boluses needed to maintain a mean arterial pressure > 65mmHg in the norepinephrine group (group N) and the ephedrine group (group E) during the first 20 minutes of the intervention.;Timepoint(s) of evaluation of this end point: During the first 20 minutes of the intervention.	—

Measure

Time frame

Main Objective: The main aim of this study is to compare the efficacy of ephedrine versus norepinephrine in the treatment of hypotension occurring after induction of general anesthesia in patients with chronic renal failure during elective surgery.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint: the difference in the number of vasopressor boluses needed to maintain a mean arterial pressure > 65mmHg in the norepinephrine group (group N) and the ephedrine group (group E) during the first 20 minutes of the intervention.;Timepoint(s) of evaluation of this end point: During the first 20 minutes of the intervention.

—

Secondary

Measure	Time frame
Secondary end point(s): During the first 20 minutes of the intervention: the difference in the rate of hypotension (TAM 160mmHg), the rate of bradycardias (CR 100/min).;Timepoint(s) of evaluation of this end point: During the first 20 minutes of the intervention	—

Countries

Belgium

Contacts

Public ContactAnesthesiology Department

CHU Brugmann

zakaria.cheffi@chu-brugmann.be3224775676

Outcome results

None listed

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