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

Early Phase 1

Completed

• Conditions: Spinal Stenosis Lumbar
• Interventions: Drug: Rocuronium Bromide

• Registration Number: NCT05619848
• Lead Sponsor: Zheng Guo

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.

Study Timeline

• Study Start: 2022-10-25
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-17
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild fat infiltration	Rocuronium Bromide	Fat infiltration rate is less than 30%
Moderate fat infiltration	Rocuronium Bromide	Fat infiltration rate is 30%\~50%
Server fat infiltration	Rocuronium Bromide	Fat infiltration rate is greater than 50%

Primary Outcome Measures

Name	Time	Method
use of rocuronium bromide	Perioperative period	average dosage

Secondary Outcome Measures

Name	Time	Method
The general condition of the paraspinal muscle	Perioperative period	Fat infiltration rate

Trial Locations

Locations (1)

Second of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China