Optimal Dosage of Remifentanil for Vertebroplasty

NCT05876039 | Completed Phase 4

• 1 other identifier: 210705163-V3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Remifentanil; Analgesia

Keywords

Vertebroplasty; Remifentanil; Target-controlled infusion; Procedural analgesia and sedation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Hypotension at the time of the trocar needle placement

  Time at the trocar needle placement

• Hypotension at the time of the bone cement injection

  Time at the bone cement injection

• Apnea with desaturation at the time of the trocar needle placement

  Time at the trocar needle placement

• Apnea with desaturation at the time of the bone cement injection

  Time at the bone cement injection

• TCI pump adjustments at the time of the trocar needle placement

  Time at the trocar needle placement

Study Arms (2)

Group remifentanil of 1.0 ng/mL

EXPERIMENTAL

Initial remifentanil effect-site concentration of 1.0 ng/mL

Drug: Initial remifentanil effect-site concentration

Group remifentanil 2.0 ng/mL

ACTIVE COMPARATOR

Initial remifentanil effect-site concentration of 2.0 ng/mL

Drug: Initial remifentanil effect-site concentration

Interventions

Initial remifentanil effect-site concentration DRUG

Different initial remifentanil effect-site concentration

Group remifentanil 2.0 ng/mL; Group remifentanil of 1.0 ng/mL

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) score of I-III patients receiving percutaneous vertebroplasty under procedural sedation and analgesia with remifentanil and propofol

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 36086764 BACKGROUND

• 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.

  PMID: 34397727 BACKGROUND

• 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.

  PMID: 23839319 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 25, 2023
• Study Start: May 20, 2023
• Primary Completion: August 24, 2024
• Study Completion: December 27, 2024
• Last Updated: January 8, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)