This trial investigates the use of esketamine in subanesthetic dosages in patients undergoing surgery performed under general anaesthesia particularly with regard to quality of postoperative analgesia and postoperative consumption of opioids.
Conditions
Interventions
Trade Name: Ketanest S 5 ml (5 mg/ml)
Product Name: Esketaminhydrochlorid
Product Code: Ketanest S 5 mg/ml
Pharmaceutical Form: Injection*
INN or Proposed INN: KETAMINE HYDROCHLORIDE
CAS Number: 18676
Sponsors
Universitätsklinikum Mannheim, Universitätsklinik für Anästhesiologie und Operative Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients classified as ASA (American Society of Anesthesiologists) physical status classification system I-III, which are planned to undergo elective non high-risk surgery performed under general anaesthesia - age 18 to 80 years - Body Mass Index > 17,5 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients classified as ASA (American Society of Anesthesiologists) physical status classification system IV-V - non elective surgery - continuous epidural anaesthesia - continuous peripheral nerve blockage - refusal to give written informed consent for participation - Patients already being included to other trials - contraindications to use of PCA (patient controlled anaesthesia) like noncompliance, dementia, communication difficulties - preoperative drug therapy with oral opioids due to chronical pain - allergies to esketamine and / or piritramide - symptomatical psychosis - drug addiction, alcoholism - neurological diseases with severe limitations of physical performance (e.g. Parkinson's disease) - uncontrolled arterial hypertension - instable angina pectoris / acute coronary syndrome (ACS) / cardiogenic shock - severe coronary arterial disease - severe congestive or acute heart failure - hyperthyreosis - pregnancy, lactation - history of apoplexy shorter than six months ago - elevated intracranial tension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is the influence of perioperative application of esketamine in subanaesthetic dosages on 1. postoperative consumption of piritramide and 2. subjective pain intensity, assessed by VAS (Visual Analogue Scale).;Secondary Objective: Secondary objectives are duration and quality of postoperative recovery process.;Primary end point(s): The main objective of this trial is the influence of perioperative application of esketamine in subanaesthtic dosages on 1. postoperative consumption of piritramide and 2. subjective pain intensity, assessed by VAS (Visual Analogue Scale). | — |
Countries
Germany
Outcome results
None listed