Optimal Dosage of Remifentanil for Vertebroplasty

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05876039
• Other study ID #: 210705163-V3
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2023
• Est. completion date: April 2025

Study information

• Verified date: May 2023
• Source: Tri-Service General Hospital
• Contact: Wei-Cheng Tseng, MD
• Phone: 886-2-2-8792-3311
• Email: ndmc_wechern[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Remifentanil

Intervention

Drug:
• Initial remifentanil effect-site concentration
Different initial remifentanil effect-site concentration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

References & Publications (3)

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 J — View 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 contro — View 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 stu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hypotension at the time of the trocar needle placement	Mean blood pressure > 30% decrease from baseline	Time at the trocar needle placement
Secondary	Hypotension at the time of the bone cement injection	Mean blood pressure > 30% decrease from baseline	Time at the bone cement injection
Secondary	Apnea with desaturation at the time of the trocar needle placement	Oxygen saturation < 95%	Time at the trocar needle placement
Secondary	Apnea with desaturation at the time of the bone cement injection	Oxygen saturation < 95%	Time at the bone cement injection
Secondary	TCI pump adjustments at the time of the trocar needle placement	Frequency of TCI pump adjustments	Time at the trocar needle placement
Secondary	TCI pump adjustments at the time of the bone cement injection	Frequency of TCI pump adjustments	Time at the bone cement injection
Secondary	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