Optimal Dosage of Remifentanil for Vertebroplasty

Phase 4

Completed

• Conditions: Remifentanil; Analgesia
• Interventions: Drug: Initial remifentanil effect-site concentration

• Registration Number: NCT05876039
• Lead Sponsor: Tri-Service General Hospital

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-16
• Study Start: 2023-05-20
• Study First Posted: 2023-05-25
• Primary Completion: 2024-08-24
• Study Completion: 2024-12-27
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group remifentanil of 1.0 ng/mL	Initial remifentanil effect-site concentration	Initial remifentanil effect-site concentration of 1.0 ng/mL
Group remifentanil 2.0 ng/mL	Initial remifentanil effect-site concentration	Initial remifentanil effect-site concentration of 2.0 ng/mL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hypotension at the time of the trocar needle placement	Time at the trocar needle placement	Mean blood pressure \> 30% decrease from baseline
Hypotension at the time of the bone cement injection	Time at the bone cement injection	Mean blood pressure \> 30% decrease from baseline
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%
TCI pump adjustments at the time of the trocar needle placement	Time at the trocar needle placement	Frequency of TCI pump adjustments
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.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan