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

NCT05619848 | Completed Early Phase 1

• 1 other identifier: yuewei20221109
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Stenosis Lumbar

Outcome Measures

Primary Outcomes (1)

• use of rocuronium bromide

  average dosage

  Perioperative period

Secondary Outcomes (1)

• The general condition of the paraspinal muscle

  Perioperative period

Other Outcomes (1)

• Muscle relaxation satisfaction score

  Perioperative period

Study Arms (3)

Mild fat infiltration

EXPERIMENTAL

Fat infiltration rate is less than 30%

Drug: Rocuronium Bromide

Moderate fat infiltration

EXPERIMENTAL

Fat infiltration rate is 30%\~50%

Drug: Rocuronium Bromide

Server fat infiltration

EXPERIMENTAL

Fat infiltration rate is greater than 50%

Drug: Rocuronium Bromide

Interventions

Rocuronium Bromide DRUG

0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation

Also known as: Midazolam, propofol, etomidate and remifentanil

Mild fat infiltration; Moderate fat infiltration; Server fat infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zheng Guo: lead

Study Sites (1)

Second of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Interventions

Rocuronium; Midazolam; Propofol; Etomidate; Remifentanil

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Study Officials

• Guo Zheng, Ph. D

  Second of Shanxi Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: October 25, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 30, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CN (1)