The effect of regional anaesthesia and sedation using dexmedetomidine on the effects of the anaesthesia after surgery

Phase 4

Completed

• Conditions: Sedation during regional anaesthesia; Surgery

• Registration Number: ISRCTN13642102
• Lead Sponsor: niversity of Crete

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Study Completion: 2023-05-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified