Optimal Dosage of Remifentanil for Vertebroplasty

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia; Remifentanil
• Intervention / Treatment: Drug: Initial remifentanil effect-site concentration

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei-Cheng Tseng, MD; Phone Number: 13815 886-2-2-8792-3311; Email: ndmc_wechern@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Remifentanil; Vertebroplasty; Target-controlled infusion; Procedural analgesia and sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 210705163-V3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No