MAC of Sevoflurane in end stage kidney disease

Determination of the minimal alveolar concentrations of sevoflurane in patients with end stage kidney disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003141-25-AT

Enrollment

Registered

2015-08-31

Start date

2015-10-06

Completion date

Unknown

Last updated

2021-05-03

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

Conditions

Renal transplantation is the curative treatment in patients with end stage kidney disease. These patients have altered intraoperative anesthetic requirements compared with patients with maintained renal function. Sevoflurane is used for anesthesia in patients with end stage kidney disease. However, it is unknown if whether Sevoflurane has the same potency as in patients with maintained renal function. The minimum alveolar concentration is a measure of the potency of volatile anesthetics.

Interventions

Trade Name: Sevoflurane Product Name: Sevoflurane Product Code: N01 Pharmaceutical Form: Inhalation vapour INN or Proposed INN: sevoflurane CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 30-65 Study group End stage kidney disease (GFR 60ml/min/1.72m2) 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 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age 65 years old History of malignant Hypothermia Hypokalemia > 5,5mmol/l

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to determine the MAC of Sevoflurane in patients undergoing renal transplantation.;Secondary Objective: Determination of the serum concentrations of met-Enkephalin, leu-Enkephalin, beta-Endorphin, substance P und neuropetide.;Primary end point(s): Determination of MAC. Observation of patients movement to initial skin incision. Patients' reaction is defined as gross movement or no movement of leg, arms or head within 1 minute after skin incision.;Timepoint(s) of evaluation of this end point: Observation period starting with skin incision and ending after 1 minute.	—

Measure

Time frame

Main Objective: The aim of this study is to determine the MAC of Sevoflurane in patients undergoing renal transplantation.;Secondary Objective: Determination of the serum concentrations of met-Enkephalin, leu-Enkephalin, beta-Endorphin, substance P und neuropetide.;Primary end point(s): Determination of MAC. Observation of patients movement to initial skin incision. Patients' reaction is defined as gross movement or no movement of leg, arms or head within 1 minute after skin incision.;Timepoint(s) of evaluation of this end point: Observation period starting with skin incision and ending after 1 minute.

—

Secondary

Measure	Time frame
Secondary end point(s): Measurement of serum concentrations of met-Enkephalin, leu-Enkephalin, beta-Endorphin, substance P und neuropetide Y. ;Timepoint(s) of evaluation of this end point: After induction of anesthesia.	—

Countries

Austria

Contacts

Public ContactStudy manager

Medical University Vienna, Department of Anesthesia, Intensive Care Medicine and Pain Management

anaesthesie_a@meduniwien.ac.at00431404004102

Outcome results

None listed

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