Optimal Dosage of Remifentanil for Vertebroplasty

Tri-Service General Hospital

Status and phase: Completed; Phase 4

Conditions: Remifentanil; Analgesia

Treatments: Drug: Initial remifentanil effect-site concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT05876039

210705163-V3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group remifentanil of 1.0 ng/mL

Experimental group

Description:

Initial remifentanil effect-site concentration of 1.0 ng/mL

Treatment:

Drug: Initial remifentanil effect-site concentration

Group remifentanil 2.0 ng/mL

Active Comparator group

Description:

Initial remifentanil effect-site concentration of 2.0 ng/mL

Treatment:

Drug: Initial remifentanil effect-site concentration