Optimal Dosage of Remifentanil for Vertebroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2024-12-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery

NCT03817359

Anesthetics Remifentanil Propofol

COMPLETED NA

Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index

NCT02890186

Anesthesia

UNKNOWN PHASE4

ANI and Remifentanil in Skull Pin Fixation.

NCT05125328

Pain, Procedural

COMPLETED PHASE4

ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care

NCT05340335

Remimazolam Orthopedic Procedures Sedatives

COMPLETED PHASE4

Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

NCT05651399

Remimazolam Propofol Orthopedic Procedures +2 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Remifentanil Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group remifentanil of 1.0 ng/mL

Initial remifentanil effect-site concentration of 1.0 ng/mL

Group Type EXPERIMENTAL

Initial remifentanil effect-site concentration

Intervention Type DRUG

Different initial remifentanil effect-site concentration

Group remifentanil 2.0 ng/mL

Initial remifentanil effect-site concentration of 2.0 ng/mL

Group Type ACTIVE_COMPARATOR

Initial remifentanil effect-site concentration

Intervention Type DRUG

Different initial remifentanil effect-site concentration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Initial remifentanil effect-site concentration

Different initial remifentanil effect-site concentration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No