Overview

Dexmedetomidine Sedation in Orthopedic Surgery

Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asklepieion Voulas General Hospital
Collaborators:
Chryssoula Staikou
Maria Tileli
Treatments:
Dexmedetomidine
Midazolam
Remifentanil
Criteria
Inclusion Criteria:

Physical status according to American Society of Anesthesiologists (ASA) I-III Patients
scheduled for orthopedic surgery

Exclusion Criteria:

Patient denial, contraindication of spinal anesthesia or any of the agents used in the
protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language
barrier, illicit substances abuse,