Optimal Dosage of Remifentanil for Vertebroplasty

• Sponsor: Tri-Service General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05876039
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 23

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Remifentanil; Analgesia	Drug: Initial remifentanil effect-site concentration	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Dosage of Remifentanil Infusion Combined With Propofol-based Total Intravenous Anesthesia in Percutaneous Vertebroplasty
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group remifentanil of 1.0 ng/mL Initial remifentanil effect-site concentration of 1.0 ng/mL	Drug: Initial remifentanil effect-site concentration; Different initial remifentanil effect-site concentration
Active Comparator: Group remifentanil 2.0 ng/mL Initial remifentanil effect-site concentration of 2.0 ng/mL	Drug: Initial remifentanil effect-site concentration; Different initial remifentanil effect-site concentration

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. Hypotension at the time of the trocar needle placement [Time at the trocar needle placement]

   Mean blood pressure > 30% decrease from baseline

2. Hypotension at the time of the bone cement injection [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 at the trocar needle placement]

   Oxygen saturation < 95%

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

   Oxygen saturation < 95%

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

   Frequency of TCI pump adjustments

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

   Frequency of TCI pump adjustments

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tri-Service General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei-Cheng Tseng, Principal Investigator, Tri-Service General Hospital
• ClinicalTrials.gov Identifier: NCT05876039
• Other Study ID Numbers: 210705163-V3
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Wei-Cheng Tseng, Principal Investigator, Tri-Service General Hospital: Vertebroplasty; Remifentanil; Target-controlled infusion; Procedural analgesia and sedation
• Additional relevant MeSH terms: Remifentanil

Study Results

No Results Posted as of May 25, 2023