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

Spinal Stenosis Lumbar Clinical Trial

— RUILS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619848
• Other study ID #: yuewei20221109
• Status: Completed
• Phase: Early Phase 1
• Start date: October 25, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2023
• Source: Second Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 30, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Drug:
• Rocuronium Bromide
0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation

Locations

Country	Name	City	State
China	Second of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zheng Guo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle relaxation satisfaction score	satisfaction score	Perioperative period
Primary	use of rocuronium bromide	average dosage	Perioperative period
Secondary	The general condition of the paraspinal muscle	Fat infiltration rate	Perioperative period