Sedation during regional anaesthesia Surgery
Conditions
Interventions
Patients undergoing orthopaedic or vascular surgery under regional anaesthesia will be randomized with the method of random numbers to receive either dexmedetomidine or propofol for intraoperative sed
Sponsors
University of Crete
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Undergoing orthopaedic or vascular surgery under regional anaesthesia 2. Age >65 years 3. Medical history and preoperative anaesthetic assessment to allow regional anesthesia to be used 4. Must know writing and reading 5. Remain in the hospital for at least four days 6. Expected postoperative survival is at least one year (on malignant neoplasms) and with a small chance of re-operation within three months
Exclusion criteria
Exclusion criteria: 1. Refuse to receive regional anesthesia or to participate in the study 2. Central nervous system disease (infectious, metabolic, degenerative, neoplastic, or major psychosis) 3. Severe vision or hearing impairment 4. Alcoholics or drug abusers 5. Severe general condition or in end-stage neoplasm 6. Contraindications for regional anaesthesia: 6.1. Coagulation disorders: 6.1.1. INR> 1.4 6.1.2. Platelet count <100,000 / µl 6.1.3. Active/uncontrolled bleeding 6.1.4. Lack of coagulation factors 6.1.5. Administration of anticoagulants/antiplatelet drugs in a prophylactic dose for thromboembolic episodes (prior to epidural puncture) 6.2. Inflammation at the lumbar region 6.3. Increased intracranial pressure of any cause or CNS tumor 7. Less than 24 points in the Mini Mental Status Exam during the preoperative assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Postoperative delirium. All patients will be monitored daily for the immediate post-operative period for the appearance of confusion or delirium or for any anesthetic or surgical complications. For the diagnosis of delirium, the Confusion Assessment Method will be used. 2. Postoperative cognitive dysfunction. The mental state of patients will be controlled by a group of assays, (European Psychometric Test - EUPT battery): 2.1. Visual Verbal Learning Test 2.2. Concept Shifting Task 2.3. Stroop Colour-Word Test 2.4. Letter-Digit Coding Test Postoperatively patients who will experience a reduction of> 20% of their performance in at least 2 of these trials will be considered to have postoperative mental dysfunction 2.5. The Cognitive Failure Questionnaire and the Zung Self-Calibrated Depression Scale will be used in the form of a questionnaire completed by the patient and a rough subjective indicator of his mental and psychological state Patients will undergo psychometric tests at three times: • Before anaesthesia and during the pre-anesthetic examination • The fourth to seventh postoperative day and before the patient leaves the hospital, and • Two to three months after surgery. If patients are unable to go to the hospital, they will be examined at home. In all three sessions, patients will be examined by the same investigator, who will not know the type of sedation given to the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The quality of sleep measured using the Pittsburgh Sleep Quality Index (PSQI) the day before surgery and all the postoperative days they remain hospitalized 2. The incidence of chronic pain after total hip or knee replacement 2-3 months after the operation measured using the painDETECT screening questionnaire | — |
Countries
Greece
Contacts
Public ContactVlasios Karageorgos
Outcome results
None listed