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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
Sedation using midazolam (initial bolus dose followed by continuous infusion)
Sedation using remifentanil (initial bolus dose followed by continuous infusion)
Asklepieion Hospital of Voula
Athens, Greece
RECRUITINGPostoperative analgesia duration
Time of first demand for analgesia (PCA first bolus dose)
Time frame: 24 hours
Postoperative pain: Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Time frame: 24 hours
Morphine consumption
Doses requested, morphine consumption in mg
Time frame: 24 hours
Rescue analgesia
Paracetamol in mg consumed
Time frame: 24 hours
Sedation
Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)
Time frame: 24 hours
Complications
Time frame: 24 hours
Delirium occurence
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.
Time frame: 24 hours
Chronic pain: Graded Chronic Pain Scale (GCPS)
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
Time frame: 6 months
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