Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery (RUILS)

February 14, 2023 updated by: Zheng Guo
To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Second of Shanxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild fat infiltration
Fat infiltration rate is less than 30%
Drug: Rocuronium Bromide
0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation
Other Names:
  • Midazolam, propofol, etomidate and remifentanil
Experimental: Moderate fat infiltration
Fat infiltration rate is 30%~50%
Drug: Rocuronium Bromide
0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation
Other Names:
  • Midazolam, propofol, etomidate and remifentanil
Experimental: Server fat infiltration
Fat infiltration rate is greater than 50%
Drug: Rocuronium Bromide
0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation
Other Names:
  • Midazolam, propofol, etomidate and remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
use of rocuronium bromide
Time Frame: Perioperative period
average dosage
Perioperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The general condition of the paraspinal muscle
Time Frame: Perioperative period
Fat infiltration rate
Perioperative period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle relaxation satisfaction score
Time Frame: Perioperative period
satisfaction score
Perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zheng Guo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Actual)

December 27, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yuewei20221109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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