Analgesia, Remifentanil
Conditions
Keywords
Vertebroplasty, Remifentanil, Target-controlled infusion, Procedural analgesia and sedation
Brief summary
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
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.
Interventions
DRUGInitial remifentanil effect-site concentration
Different initial remifentanil effect-site concentration
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate analgesia at the time of the trocar needle insertion | Time at the trocar needle placement | Remaining moveless at the time of the trocar needle insertion |
| Adequate analgesia at the time of the bone cement injection | Time at the bone cement injection | Remaining moveless at the time of the bone cement injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apnea with desaturation at the time of the trocar needle placement | Time at the trocar needle placement | Oxygen saturation \< 95% |
| Apnea with desaturation at the time of the bone cement injection | Time at the bone cement injection | Oxygen saturation \< 95% |
| Hypotension at the time of the trocar needle placement | Time at the trocar needle placement | Mean blood pressure \> 30% decrease from baseline |
| TCI pump adjustments at the time of the bone cement injection | Time at the bone cement injection | Frequency of TCI pump adjustments |
| Numeric rating scale | Postoperative one hour | 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. |
| TCI pump adjustments at the time of the trocar needle placement | Time at the trocar needle placement | Frequency of TCI pump adjustments |
| Hypotension at the time of the bone cement injection | Time at the bone cement injection | Mean blood pressure \> 30% decrease from baseline |
Countries
Taiwan
Outcome results
None listed