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Clinical trial

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

ID
Name
210705163-V3
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2025-04-01
Trial end
2025-04-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Initial remifentanil effect-site concentration
Different initial remifentanil effect-site concentration
Arms:
Group remifentanil 2.0 ng/mL, Group remifentanil of 1.0 ng/mL
Size
80
Primary endpoint
Adequate analgesia at the time of the trocar needle insertion
Time at the trocar needle placement
Adequate analgesia at the time of the bone cement injection
Time at the bone cement injection
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-05-25

1 organization

1 product

2 indications

Organization
Tri-Service General Hospital
Product
Remifentanil
Indication
Remifentanil
Indication
Analgesic