Optimal Dosage of Remifentanil for Vertebroplasty

Study Overview
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Brief Summary
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Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects.

Detailed Description
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Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Many anesthetic methods have been used in percutaneous vertebroplasty; however, there is no gold-standard method. Procedural analgesia and sedation (PAS) are one of the commonly used approaches. For its unique properties, including rapid onset, precise intraoperative control, and a fast recovery profile, remifentanil is preferable to other opioids administration in a target-controlled infusion (TCI) pump. Combination of remifentanil with propofol may improve sedation experience; however, it can increase a risk of respiratory depression. Moreover, propofol and remifentanil are often administered with 2 TCI pumps to, respectively, provide hypnotic and analgesic effects, which together are considered to be an ideal anesthetic technique.

Official Title
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Comparison of Two Dosage of Remifentanil Infusion Combined With Propofol-based Total Intravenous Anesthesia in Percutaneous Vertebroplasty

Conditions
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Remifentanil, Analgesia

Intervention / Treatment
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* Drug: Initial remifentanil effect-site concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) score of I-III patients receiving percutaneous vertebroplasty under procedural sedation and analgesia with remifentanil and propofol Exclusion Criteria: Age < 20 or > 80 years ASA classifications > III Pregnancy Known allergies to opioids, propofol or any drugs used in the study Emergency surgery Patient refusal

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group remifentanil of 1.0 ng/mL<br>Initial remifentanil effect-site concentration of 1.0 ng/mL | Drug: Initial remifentanil effect-site concentration<br>* Different initial remifentanil effect-site concentration<br>|
| Active Comparator: Group remifentanil 2.0 ng/mL<br>Initial remifentanil effect-site concentration of 2.0 ng/mL | Drug: Initial remifentanil effect-site concentration<br>* Different initial remifentanil effect-site concentration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate analgesia at the time of the trocar needle insertion | Remaining moveless at the time of the trocar needle insertion | Time at the trocar needle placement | 
| Adequate analgesia at the time of the bone cement injection | Remaining moveless at the time of the bone cement injection | Time at the bone cement injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension at the time of the trocar needle placement | Mean blood pressure > 30% decrease from baseline | Time at the trocar needle placement | 
| Hypotension at the time of the bone cement injection | Mean blood pressure > 30% decrease from baseline | Time at the bone cement injection | 
| Apnea with desaturation at the time of the trocar needle placement | Oxygen saturation < 95% | Time at the trocar needle placement | 
| Apnea with desaturation at the time of the bone cement injection | Oxygen saturation < 95% | Time at the bone cement injection | 
| TCI pump adjustments at the time of the trocar needle placement | Frequency of TCI pump adjustments | Time at the trocar needle placement | 
| TCI pump adjustments at the time of the bone cement injection | Frequency of TCI pump adjustments | Time at the bone cement injection | 
| Numeric rating scale | Postoperative numeric rating scale. NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. | Postoperative one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebroplasty, Remifentanil, Target-controlled infusion, Procedural analgesia and sedation