Clinical trial NCT05876039: Optimal Dosage of Remifentanil for Vertebroplasty
Official title: Comparison of Two Dosage of Remifentanil Infusion Combined with Propofol-based Total Intravenous Anesthesia in Percutaneous Vertebroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Remifentanil
Analgesia
Keywords: Vertebroplasty
Remifentanil
Target-controlled infusion
Procedural analgesia and sedation
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adequate analgesia at the time of the trocar needle insertion
timeFrame: Time at the trocar needle placement
measure: Adequate analgesia at the time of the bone cement injection
timeFrame: Time at the bone cement injection
Secondary outcomes:
measure: Hypotension at the time of the trocar needle placement
timeFrame: Time at the trocar needle placement
measure: Hypotension at the time of the bone cement injection
timeFrame: Time at the bone cement injection
measure: Apnea with desaturation at the time of the trocar needle placement
timeFrame: Time at the trocar needle placement
measure: Apnea with desaturation at the time of the bone cement injection
timeFrame: Time at the bone cement injection
measure: TCI pump adjustments at the time of the trocar needle placement
timeFrame: Time at the trocar needle placement
measure: TCI pump adjustments at the time of the bone cement injection
timeFrame: Time at the bone cement injection
measure: Numeric rating scale
timeFrame: Postoperative one hour
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
citation: Lai HC, Chen CL, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during transrectal ultrasound-guided prostate biopsy under procedural analgesia and sedation: A randomized controlled study. Medicine (Baltimore). 2022 Sep 9;101(36):e30466. doi: 10.1097/MD.0000000000030466.
citation: Lai HC, Tsai YT, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during percutaneous transluminal balloon angioplasty under monitored anesthesia care: A randomized controlled study. Medicine (Baltimore). 2021 Jul 30;100(30):e26780. doi: 10.1097/MD.0000000000026780.
citation: Cannata F, Spinoglio A, Di Marco P, Luzi M, Canneti A, Ricciuti G, Reale C. Total intravenous anesthesia using remifentanil in extracorporeal shock wave lithotripsy (ESWL). Comparison of two dosages: a randomized clinical trial. Minerva Anestesiol. 2014 Jan;80(1):58-65. Epub 2013 Jul 9.