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Completed

NCT Number: NCT05619848

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

To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Second of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rocuronium bromide

Drug

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

Primary outcomes

  1. use of rocuronium bromide

    Time frame: Perioperative period

    average dosage

Secondary outcomes

  1. The general condition of the paraspinal muscle

    Time frame: Perioperative period

    Fat infiltration rate

Other outcomes

  1. Muscle relaxation satisfaction score

    Time frame: Perioperative period

    satisfaction score

Sponsors and collaborators

Lead sponsor

Zheng Guo

Other

Registry information

Acronym: RUILS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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