Back to resultsEffect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery (RUILS)
Primary Purpose
Spinal Stenosis Lumbar
Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Rocuronium Bromide
Sponsored by
About this trial
This is an interventional other trial for Spinal Stenosis Lumbar
Eligibility Criteria
Inclusion Criteria: Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy. Exclusion Criteria: refusal to participate by the present experimenter; those with severe cardio-cerebrovascular disease, severe hepatic and renal dysfunction; taking medications affecting the neuromuscular junction; area of monitoring site for skin breakers; patients with intraoperative bleeding, anaphylactic shock, or other serious complications; patients requiring intraoperative neurophysiological monitoring (including sensory, motor evoked potentials).
Sites / Locations
- Second of Shanxi Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Mild fat infiltration
Moderate fat infiltration
Server fat infiltration
Arm Description
Fat infiltration rate is less than 30%
Fat infiltration rate is 30%~50%
Fat infiltration rate is greater than 50%
Outcomes
Primary Outcome Measures
use of rocuronium bromide
average dosage
Secondary Outcome Measures
The general condition of the paraspinal muscle
Fat infiltration rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05619848
Brief Title
Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
Acronym
RUILS
Official Title
Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zheng Guo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.
Detailed Description
Select the patients who will receive posterior lumbar surgery in the Second Hospital of Shanxi Medical University. According to the classification criteria of fat infiltration, it will be divided into three groups: mild, moderate and severe. This study will pump and titrate rocuronium bromide under the monitoring of muscle relaxation during the operation, record the dosage of rocuronium bromide and the duration of pump injection, and evaluate its clinical effect. Postoperative results include the use and clinical effect of rocuronium, which will be counted after the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis Lumbar
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild fat infiltration
Arm Type
Experimental
Arm Description
Fat infiltration rate is less than 30%
Arm Title
Moderate fat infiltration
Arm Type
Experimental
Arm Description
Fat infiltration rate is 30%~50%
Arm Title
Server fat infiltration
Arm Type
Experimental
Arm Description
Fat infiltration rate is greater than 50%
Intervention Type
Drug
Intervention Name(s)
Rocuronium Bromide
Other Intervention Name(s)
Midazolam, propofol, etomidate and remifentanil
Intervention Description
0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation
Primary Outcome Measure Information:
Title
use of rocuronium bromide
Description
average dosage
Time Frame
Perioperative period
Secondary Outcome Measure Information:
Title
The general condition of the paraspinal muscle
Description
Fat infiltration rate
Time Frame
Perioperative period
Other Pre-specified Outcome Measures:
Title
Muscle relaxation satisfaction score
Description
satisfaction score
Time Frame
Perioperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy.
Exclusion Criteria:
refusal to participate by the present experimenter; those with severe cardio-cerebrovascular disease, severe hepatic and renal dysfunction; taking medications affecting the neuromuscular junction; area of monitoring site for skin breakers; patients with intraoperative bleeding, anaphylactic shock, or other serious complications; patients requiring intraoperative neurophysiological monitoring (including sensory, motor evoked potentials).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo Zheng, Ph. D
Organizational Affiliation
Second of Shanxi Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Second of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
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