Spinal Stenosis LumbarEarly Phase 1RUILSNCT05619848
Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
A Early Phase 1 study testing Rocuronium Bromide in people with Spinal Stenosis Lumbar, run by Zheng Guo at 1 site in China.
Trial summary
To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Rocuronium Bromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2022to 30 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.
Read the 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.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Rocuronium Bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium BromideDrug
Also called Midazolam, propofol, etomidate and remifentanil
0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation
| Study group | Role | What they receive |
|---|---|---|
| Mild fat infiltration | Experimental | Fat infiltration rate is less than 30% Receives: Drug: Rocuronium Bromide |
| Moderate fat infiltration | Experimental | Fat infiltration rate is 30%~50% Receives: Drug: Rocuronium Bromide |
| Server fat infiltration | Experimental | Fat infiltration rate is greater than 50% Receives: Drug: Rocuronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of rocuronium bromide
average dosage
Measured: Perioperative period
Secondary outcomes (1)
The general condition of the paraspinal muscle
Fat infiltration rate
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start25 Oct 2022
- Primary completion27 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zheng Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Guo Zheng, Ph. D, Study chair, Second of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619848
- Sponsor's protocol ID
- yuewei20221109
- Acronym
- RUILS
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
- ClinicalTrials.gov ID
- NCT05619848
- Acronym / sponsor ID
- RUILS / yuewei20221109
- Conditions
- Spinal Stenosis Lumbar
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Zheng GuoUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild fat infiltration | Experimental | Drug: Rocuronium BromideFat infiltration rate is less than 30% |
| Moderate fat infiltration | Experimental | Drug: Rocuronium BromideFat infiltration rate is 30%~50% |
| Server fat infiltration | Experimental | Drug: Rocuronium BromideFat infiltration rate is greater than 50% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium BromideAlso: Midazolam, propofol, etomidate and remifentanil0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation | Drug | Mild fat infiltration, Moderate fat infiltration, Server fat infiltration |
Primary outcome
use of rocuronium bromide
Time frame: Perioperative period
average dosage
1 secondary outcome
The general condition of the paraspinal muscle
Time frame: Perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo Zheng, Ph. D study chair
Second of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rocuronium Bromide in people with Spinal Stenosis Lumbar, run by Zheng Guo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of rocuronium bromide (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.