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Completed

NCT Number: NCT05876039

Optimal Dosage of Remifentanil for 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.

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Key information

Conditions

Remifentanil Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initial remifentanil effect-site concentration

Drug

Different initial remifentanil effect-site concentration

Primary outcomes

  1. Adequate analgesia at the time of the trocar needle insertion

    Time frame: Time at the trocar needle placement

    Remaining moveless at the time of the trocar needle insertion

  2. Adequate analgesia at the time of the bone cement injection

    Time frame: Time at the bone cement injection

    Remaining moveless at the time of the bone cement injection

Secondary outcomes

  1. Hypotension at the time of the trocar needle placement

    Time frame: Time at the trocar needle placement

    Mean blood pressure > 30% decrease from baseline

  2. Hypotension at the time of the bone cement injection

    Time frame: Time at the bone cement injection

    Mean blood pressure > 30% decrease from baseline

  3. Apnea with desaturation at the time of the trocar needle placement

    Time frame: Time at the trocar needle placement

    Oxygen saturation < 95%

  4. Apnea with desaturation at the time of the bone cement injection

    Time frame: Time at the bone cement injection

    Oxygen saturation < 95%

  5. TCI pump adjustments at the time of the trocar needle placement

    Time frame: Time at the trocar needle placement

    Frequency of TCI pump adjustments

  6. TCI pump adjustments at the time of the bone cement injection

    Time frame: Time at the bone cement injection

    Frequency of TCI pump adjustments

  7. Numeric rating scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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