I95.2 I95.8
Conditions
Interventions
Group 1: Treatment of a perioperative episode of arterial hypotension by AKRINOR, where the indication for treatment and the appropriate dose of the drug AKRINOR is individually chosen by the attendin
Sponsors
ratiopharm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inpatients requiring IV treatment with Cafedrine/Theodrenaline or Ephedrine (Sintetica) during surgical interventions due to acute arterial hypotension with signed informed consent form and treated according to the SmPC Inpatients with tight blood pressure monitoring and pulse measurement (at least interval of 2 minutes and/or at least 7 measurements up to 15 minutes after first application of Cafedrine/Theodrenaline or Ephedrine) Male of female inpatients undergoing non-emergency surgery under general anaesthesia) with systolic blood pressure (SBP) < 100 mmHg and / or ? 20 % drop (SBP) compared to preoperative baseline value who are 50 years or older, have pre-existing morbidity (defined as an ASA-classification of 2-4), receiving anaesthesia induction with propofol and fentanyl (= 0.2 mg) (or equivalent) as the main induction agents ( OR ) parturients undergoing non-emergency cesarean section under spinal anaesthesia presenting with SBP < 100 mmHg and / or ? 10 % drop (SBP) compared to preoperative baseline value, 18 years or older
Exclusion criteria
Exclusion criteria: patients who have any of the contraindication for the use of Cafedrine/Theodrenaline or Ephedrine Meduna (Sintetica) according to the current German SmPC patients undergoing prophylactic treatment with Cafedrine/Theodrenaline or Ephedrine or other antihypotensive drugs any signs of sepsis, septic shock or systemic inflammation response syndrome (SIRS) intracranial or cardiac surgery only for parturients undergoing cesarean section in spinal anaesthesia: - high-risk pregnancy - multigravida parturients - amnion infection syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incidence of HR = 100 min-1 during the first 15 min after initial medication of cafedrine/theodrenalin or ephedrine . 2. Weighted (squared) undercut of the individually determined systolic arterial pressure (RRmin), that needs to be achieved according to the discretion of the attending anaesthesiologist within the first 15 minutes after pharmacologic treatment of arterial hypotension. This measure ("weighted undercut") is reflected by the area under the curve (AUC) of the actual arterial blood pressure and RRmin. Since blood presure is usually recorded discontinually the AUC is the sum of n trapezes, that can be constructed by periods tn+1 - tn and the squared distances of the actual pressures to tn : RRsys ( tn ) or to tn + 1 : RRsys ( tn + 1 ) from the lower limit RRmean are formed . Here, n refers to the predetermined time points where blood pressure measurements are made. The distances are squared in order to achieve a weight to strong variations. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) weighted overshoot of arterial blood pressure exceeding an upper limit defined as 1.3-fold the individually determined systolic BP at least to be achieved (RRmin) within the first 15 minutes after initial application of Cafedrine/Theodrenaline or Ephedrine (as AUC between the curve of systolic BP and the limit 1.3 x RRmin) (2) sum of violations of actual arterial blood pressure below RRmin and over 1.3x RRmin (3) percent increase of systolic blood pressure 1, 2, 5 and 10 minutes after initial administration of Cafedrine/Theodrenaline or Ephedrine compared to baseline blood pressure (baseline = blood pressure at making the decision to treat hypotension) (4) time period to reach the individually defined systolic blood pressure (RRmin) after initial administration of Cafedrine/Theodrenaline or Ephedrine (5) precision measured as variance of the systolic blood presure within the first 15 minutes after initial administration of Cafedrine/Theodrenaline or Ephedrine (6) time until first significant BP increase is reached (defined as 10% increase compared to baseline) (7) number of additional boli of the initially administered antihypotensive drug within 15 minutes (8) incidence and severity of early postoperative delirium, defined as 2 or more points within the Nu-DESC test (patients receiving general anaesthesia only) (9) severity of fetal acidosis based onto pH value of arterial cord blood of the newborn (group of patients undergoing Cesarean section only) (10) severity of fetal acidosis based onto base excess of arterial cord blood of the newborn ((group of patients undergoing Cesarean section only) (11) neonatal APGAR score of the newborn (group of patients undergoing Cesarean section only) | — |
Countries
Germany
Contacts
Public ContactLeopold Eberhart
Klinik für Anästhesie und Intensivtherapie, Philipps-Universität Marburg
Outcome results
None listed