cafedrine--theodrenaline-drug-combination and Hypotension

Hypotension in anesthesia and obstetric anesthesia in particular, is a widespread problem. After the temporary withdrawal of Akrinor from the market, the internationally available drug ephedrine is available for prevention and therapy of hypotension in anesthesia and its effect is comparable with Akrinor. In obstetric epidural anesthesia the intravenous prophylactic drug application of ephedrine seems to be superior to therapeutic application only. The aim of this overview is to show alternatives to the currently administered catecholamines for prevention of hypotension in obstetric anesthesia.

Topics: Acidosis; Adult; Anesthesia, Conduction; Anesthesia, Epidural; Anesthesia, Obstetrical; Cardiovascular Agents; Drug Combinations; Ephedrine; Female; Humans; Hypotension; Infant, Newborn; Pregnancy; Theophylline; Vasoconstrictor Agents

To compare the effectiveness of 20:1 cafedrine/theodrenaline approved for use in Germany to ephedrine in the restoration of arterial blood pressure and on post-operative outcomes in patients with intra-operative arterial hypotension of any origin under standard clinical practice conditions.. 'HYPOTENS' is a national, multi-center, prospective, open-label, two-armed, non-interventional study. Effectiveness and post-operative outcome following cafedrine/theodrenaline or ephedrine therapy will be evaluated in two cohorts of hypotensive patients. Cohort A includes patients aged ≥50 years with ASA-classification 2-4 undergoing non-emergency surgical procedures under general anesthesia. Cohort B comprises patients undergoing Cesarean section under spinal anesthesia. Participating surgical departments will be assigned to a treatment arm by routinely used anti-hypotensive agent. To minimize bias, matched department pairs will be compared in a stratified selection process. The composite primary end-point is the lower absolute deviation from individually determined target blood pressure (IDTBP) and the incidence of heart rate ≥100 beats/min in the first 15 min. Secondary end-points include incidence and degree of early post-operative delirium (cohort A), severity of fetal acidosis in the newborn (cohort B), upper absolute deviation from IDTBP, percentage increase in systolic blood pressure, and time to IDTBP.. This open-label, non-interventional study design mirrors daily practice in the treatment of patients with intra-operative hypotension and ensures full treatment decision autonomy with respect to each patient's individual condition. Selection of participating sites by a randomization process addresses bias without interfering with the non-interventional nature of the study. First results are expected in 2018. ClinicalTrials.gov identifier: NCT02893241; DRKS identifier: DRKS00010740.

Topics: Adult; Anesthesia, Obstetrical; Anesthesia, Spinal; Blood Pressure; Cesarean Section; Cohort Studies; Drug Combinations; Ephedrine; Female; Germany; Heart Rate; Humans; Hypotension; Infant, Newborn; Middle Aged; Pregnancy; Prospective Studies; Theophylline; Vasoconstrictor Agents

The main objective of this study was to assess the impact of phenylephrine and cafedrine/theodrenaline on the mother and newborn after spinal anaesthesia for caesarean section.. University teaching hospital.. A single-centre retrospective data cohort study.. All obstetric patients who were scheduled for caesarean section in a 2-year period.. Administration of either intravenous phenylephrine prophylactically or cafedrine/theodrenaline (Akrinor) reactively to maintain blood pressure after spinal anaesthesia.. Maternal hypotension, heart rate during caesarean section and after admission to IMC, fetal arterial cord pH and base excess levels, maternal volume resuscitation and the use of rescue medication.. 852 data sets could be included: n=440 Akrinor, n=412 in the phenylephrine cohort. During caesarean section blood pressure was slightly higher in the phenylephrine group compared with the Akrinor group, while hypotension <100 mm Hg systolic blood pressure (SBP) occurred significantly more often during arrival at the IMC after surgery when phenylephrine was used. Heart rate was lower and rescue medication was significantly more frequently given in the phenylephrine cohort. Irrespective of the medication used, women with baseline levels of <120 mm Hg SBP had a high risk to develop hypotension <100 mm Hg after spinal anaesthesia for caesarean section. While there was no statistical difference in mean umbilical arterial pH levels, the incidence of acidosis, defined as pH <7.2, was significantly higher with phenylephrine.. Phenylephrine was not superior to Akrinor to treat spinal anaesthesia-induced maternal hypotension during caesarean section.. DRKS00025795.

Topics: Anesthesia, Obstetrical; Anesthesia, Spinal; Cesarean Section; Cohort Studies; Female; Humans; Hypotension; Infant, Newborn; Phenylephrine; Pregnancy; Retrospective Studies; Vasoconstrictor Agents

Topics: Aged; Atropine; Bradycardia; Cholinergic Antagonists; Drug Combinations; Female; Germany; Glycopyrrolate; Humans; Hypotension; Intraoperative Complications; Male; Middle Aged; Ophthalmologic Surgical Procedures; Preanesthetic Medication; Reflex; Retrospective Studies; Sialorrhea; Theophylline; Vagus Nerve

There is insufficient knowledge about the hemodynamic effects of cafedrine/theodrenaline (caf/theo), a commercially available drug combination, to treat hypotension.. This prospective observational study investigated the hemodynamic effects of caf/theo on anesthesia-induced hypotension in 20 patients scheduled for elective major abdominal surgery. After induction of total intravenous anesthesia (TIVA) with propofol and remifentanil, a decrease in mean arterial blood pressure (MAP) below 60 mm Hg (n = 12) was treated with 60 mg/3 mg caf/theo. The systemic vascular resistance index (SVRI), cardiac index (CI), global end-diastolic index (GEDI), maximum pressure increase in the aorta (dPmx) and global ejection fraction (GEF) were assessed by transpulmonary thermodilution (PiCCO2-Monitor).. The MAP increased by approximately 60% 10 min after administration of caf/theo. The increase in MAP was a result of the simultaneous effects on various cardiovascular determinants. An increase in peripheral resistance (SVRI +42%) and CI (+17%) could be determined. Data further indicated that the increase in CI was a consequence of an increase in both dPmx (+31%) and GEDI (+9%) but the GEF remained constant.. In anesthesia-induced hypotension caf/theo effectively increased the mean arterial blood pressure by combined effects on preload, contractility, and afterload without altering cardiovascular efficiency.

Topics: Adult; Aged; Anesthesia, General; Anesthetics, Intravenous; Blood Pressure; Drug Combinations; Female; Hemodynamics; Humans; Hypotension; Hypotension, Controlled; Male; Middle Aged; Propofol; Prospective Studies; Remifentanil; Theophylline

Hypotensive states that require fast stabilisation of blood pressure can occur during anaesthesia. In 1963, the 20:1 mixture of cafedrine/theodrenaline (Akrinor) was introduced in Germany for use in anaesthesia and emergency medicine in the first-line management of hypotensive states. Though on the market for many years, few pharmacodynamic data are available on this combination net beta-mimetic agent.. This study aimed to examine the drug combination in real-life clinical practice and recorded time to 10 % mean arterial blood pressure (MAP) increase and heart rate. Furthermore, potential factors that influence drug effectiveness under anaesthesia were assessed.. Data were collected within a standardised anaesthesia protocol. A total of 353 consecutive patients (female/male = 149/204) who received cafedrine/theodrenaline after a drop in MAP ≥ 5% were included in the study. The time to 10 % increase in MAP, dosage of cafedrine/theodrenaline, volume loading, blood pressure and heart rate were monitored over time.. Patients were a mean (standard deviation) of 64.4 ± 15.1 years old with a baseline MAP of 82 ± 14 mmHg, which dropped to a mean of 63 ± 10 mmHg during anaesthesia without gender differences. Cafedrine/theodrenaline (1.27 ± 1.0 mg/kg; 64 ± 50 µg/kg) significantly increased MAP (p < 0.001) by 11 ± 16 mmHg within 5 min, reaching peak values within 17.4 ± 9.0 min. Heart rate was not affected in a clinically significant manner. Cafedrine/theodrenaline induced a 10% MAP increase after 7.2 ± 4.6 min (women) and after 8.6 ± 6.3 min (men) (p = 0.018). Independent of gender, the dose of cafedrine/theodrenaline required to achieve the observed MAP increase of 14 ± 16 mmHg at 15 min was significantly different in patients with heart failure [1.78 ± 1.67 mg/kg (cafedrine)/89.0 ± 83.5 µg/kg (theodrenaline)] compared with healthy patients [1.16 ± 0.77 mg/kg (cafedrine)/58.0 ± 38.5 µg/kg (theodrenaline)] (p = 0.005). Concomitant medication with beta-blocking agents significantly prolonged the time to 10 % MAP increase [9.0 ± 7.0 vs. 7.3 ± 4.3 min (p = 0.008)].. Cafedrine/theodrenaline quickly restores MAP during anaesthesia. Female gender is associated with higher effectiveness, while heart failure and beta-blocker administration lower the anti-hypotonic effect. Prospective studies in defined patient populations are warranted to further characterise the effect of cafedrine/theodrenaline.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Anesthesia; Blood Pressure; Cardiovascular Agents; Drug Combinations; Drug Interactions; Female; Heart Failure; Heart Rate; Humans; Hypotension; Intraoperative Care; Kaplan-Meier Estimate; Male; Middle Aged; Retrospective Studies; Sex Characteristics; Theophylline

Maternal hypotension is the most frequent complication in spinal anesthesia for Cesarean delivery. Malperfusion of the foetus and nausea and vomiting of the mother are hallmarks of maternal hypotension. In this retrospective data analysis and anesthesia protocols we have investigated to explore the effects of therapeutic interventions for hypotension with cafedrine/theodrenaline (Akrinor® ) during spinal anesthesia for elective Cesarean section.. In a retrospective study anesthesia charts of 173 parturients undergoing spinal anesthesia for Cesarean delivery with 10mg hyperbaric bupivacaine + 5 µg sufentanil were reviewed for 30 min after onset of hypotension with respect to blood pressure, heart rate, respiration rate, as well as APGAR scores and umbilical arterial pH. Maternal data were compared to baseline values recorded and documented immediately before placing the spinal anesthesia in the operating room. The cohort was divided into two groups according to their hemodynamic response to spinal anesthesia: 117 parturients had a drop of systolic blood pressure to <120 mmHg or <80% of baseline blood pressure and were therefore treated with Akrinor® (cafedrine/theodrenaline; treatment group); 56 patients remained within the specified limits (non-treatment group). Maternal cardiovascular parameters and newborn outcome between the groups were compared.. Both groups were comparable with regard to baseline characteristics. In the treatment group one minute after the first application of cafedrine (43 mg)/theodrenaline (2.2 mg) mean systolic blood pressure raised from 108.6 mmHg to 117.2 mmHg (P=0.0004), mean of maximal changes of systolic blood pressure after the first application of Akrinor® was 21.3 mmHg. Blood pressure levels of the non-treatment group were regained in the treatment group 8 min after hypotension onset and remained at that level until the end of 30 min observation. No clinically relevant changes of heart rate were detectable. While mean APGAR score one minute post partum was significantly higher in the treatment group (8.9±1.2 vs. 8.4±1.1 P=0.043), mean umbilical arterial cord pH was 7.3±0.1 and APGAR scores 5 and 10 minutes postpartum did not differ significantly.. The results of this study confirm a rapid and sustained increase in blood pressure after application of Akrinor® for treatment of sympathicolysis induced hypotension. No negative impact of Akrinor® on umbilical arterial cord pH and APGAR scores was observed.

Topics: Adult; Anesthesia, Spinal; Blood Pressure; Cesarean Section; Drug Combinations; Elective Surgical Procedures; Female; Humans; Hypotension; Infant, Newborn; Medical Records; Nausea; Pregnancy; Retrospective Studies; Severity of Illness Index; Theophylline; Treatment Outcome; Vomiting

The effect of a fractional epidural blockade on acute pancreatitis was investigated in a prospective study. PATIENTS AND METHODS. Thoracic (20 patients) or lumbar (six patients) epidural blockade was carried out in 26 patients with severe abdominal conditions comprising sub-ileus in 100%, pancreatic edema indicated by sonography/computer tomography in 57.8%, and necrosis of the pancreas in 34.6%. RESULTS. On average, 3.4 (1-6) injections with single doses of 6-20 ml 0.25% bupivacaine were injected per day. In four patients, morphine (up to 4 mg per 24 h) was added to the local anesthetic. The duration of treatment was between 1 and 15 days. After 10.5% of the injections, the systolic pressure decreased by more than 20%, and after 12.8% of the injections the blood pressure decreased by more than 30%. Hypotension of more than 30% was treated with 0.3 to 0.5 ml theodrenaline (Akrinor) and/or 0.1 to 0.2 mg dihydro-ergotamine (Dihydergot). General analgesics had to be administered in addition on 21.8% of the treatment days and intensive care treatment (artificial ventilation) on 32% of the treatment days. The duration of epidural analgesia varied between 1 and 15 days depending on the intensity of symptoms (pain, ileus). Within 4 days, the enzyme activity of the lipase fell from 8120 to 427 IU, and that of alpha amylase fell from 1401 to 143 IU. In 3 patients laparotomy (for drainage) was performed. An ERCP was carried out in 16 patients. Cardiopulmonary failure necessitated artificial ventilation over a period of 1-15 days in 6 patients; the epidural blockade was continued during the artificial ventilation. Cholecystectomy was carried out as an interval operation in 6 patients. No neurological complications were observed. All patients survived and were discharged from hospital.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Analgesia, Epidural; Bupivacaine; Cholangiopancreatography, Endoscopic Retrograde; Dihydroergotamine; Drug Combinations; Humans; Hypotension; Middle Aged; Morphine; Pancreatitis; Prospective Studies; Respiration, Artificial; Theophylline

Topics: Cardiovascular System; Central Nervous System Stimulants; Drug Combinations; Electrocardiography; Humans; Hypotension; Pharmacology; Theophylline; Time