Dexmedetomidine Sedation in Orthopedic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia

Conditions
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Hallux Valgus and Bunion, Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Dexmedetomidine sedation | Drug: Dexmedetomidine<br>* Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)<br>|
| Active Comparator: Group B<br>Midazolam sedation | Drug: Midazolam<br>* Sedation using midazolam (initial bolus dose followed by continuous infusion)<br>|
| Active Comparator: Group C<br>Remifentanil sedation | Drug: Remifentanil<br>* Sedation using remifentanil (initial bolus dose followed by continuous infusion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia duration | Time of first demand for analgesia (PCA first bolus dose) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: Numerical Rating Scale (NRS) | Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever) | 24 hours | 
| Morphine consumption | Doses requested, morphine consumption in mg | 24 hours | 
| Rescue analgesia | Paracetamol in mg consumed | 24 hours | 
| Sedation | Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient) | 24 hours | 
| Complications |  | 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. | 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 | 6 months |