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

NCT ID: NCT05619848

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Stenosis Lumbar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mild fat infiltration

Fat infiltration rate is less than 30%

Group Type EXPERIMENTAL

Rocuronium Bromide

Intervention Type DRUG

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

Moderate fat infiltration

Fat infiltration rate is 30%\~50%

Group Type EXPERIMENTAL

Rocuronium Bromide

Intervention Type DRUG

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

Server fat infiltration

Fat infiltration rate is greater than 50%

Group Type EXPERIMENTAL

Rocuronium Bromide

Intervention Type DRUG

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

Interventions

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Rocuronium Bromide

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

Intervention Type DRUG

Other Intervention Names

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Midazolam, propofol, etomidate and remifentanil

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zheng Guo

OTHER

Sponsor Role lead

Responsible Party

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Zheng Guo

Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guo Zheng, Ph. D

Role: STUDY_CHAIR

Second of Shanxi Medical University

Locations

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Second of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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yuewei20221109

Identifier Type: -

Identifier Source: org_study_id

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