Hallux Valgus and Bunion, Sedation
Conditions
Brief 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.
Interventions
DRUGDexmedetomidine
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
DRUGMidazolam
Sedation using midazolam (initial bolus dose followed by continuous infusion)
DRUGRemifentanil
Sedation using remifentanil (initial bolus dose followed by continuous infusion)
Sponsors
Maria Tileli
Chryssoula Staikou
Asklepieion Voulas General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesia duration | 24 hours | Time of first demand for analgesia (PCA first bolus dose) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | 24 hours | Doses requested, morphine consumption in mg |
| Rescue analgesia | 24 hours | Paracetamol in mg consumed |
| Sedation | 24 hours | Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient) |
| Postoperative pain: Numerical Rating Scale (NRS) | 24 hours | Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever) |
| Delirium occurence | 24 hours | Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium. |
| Chronic pain: Graded Chronic Pain Scale (GCPS) | 6 months | Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting |
| Complications | 24 hours | — |
Countries
Greece
Contacts
Primary ContactAlexandros Makris, MD, MSc, PhD
Backup ContactMaria Tileli, MD
Outcome results
None listed