Optimal Dosage of Remifentanil for Vertebroplasty

Tri-Service General Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Remifentanil Analgesia

Interventions

Initial remifentanil effect-site concentrationDRUG

Different initial remifentanil effect-site concentration

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Adequate analgesia at the time of the trocar needle insertion

Remaining moveless at the time of the trocar needle insertion

Time frame: 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 frame: Time at the bone cement injection

Secondary Outcomes

Hypotension at the time of the trocar needle placement

Mean blood pressure \> 30% decrease from baseline

Time frame: Time at the trocar needle placement

Hypotension at the time of the bone cement injection

Mean blood pressure \> 30% decrease from baseline

Time frame: Time at the bone cement injection

Apnea with desaturation at the time of the trocar needle placement

Oxygen saturation \< 95%

Time frame: Time at the trocar needle placement

Apnea with desaturation at the time of the bone cement injection

Oxygen saturation \< 95%

Time frame: Time at the bone cement injection

TCI pump adjustments at the time of the trocar needle placement

Frequency of TCI pump adjustments

Time frame: Time at the trocar needle placement

TCI pump adjustments at the time of the bone cement injection

Frequency of TCI pump adjustments

Data from ClinicalTrials.gov

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