Cholecystectomy, LaparoscopicNCT02575443
Neuromuscular Block and Anesthetic Depth Monitoring
A study testing Rocuronium (MB group) and Rocuronium (DB group) in people with Cholecystectomy, Laparoscopic, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Rocuronium (MB group) and Rocuronium (DB group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Sep 2017
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gall bladder disease
- American Society of Anesthesiologist physical status 1 or 2
Who cannot join
- Pregnancy
- Body mass index < 16
- Body mass index >30
- Neuromuscular disease
- Previous intraabdominal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS).
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Rocuronium (MB group), Rocuronium (DB group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium (MB group)Drug
Count of train-of-four: 1-2 Titration of rocuronium dose
Rocuronium (DB group)Drug
Post-tetanic count: 1-2 Titration of rocuronium dose
| Study group | Role | What they receive |
|---|---|---|
| Moderate block (MB) group | Experimental | Not described Receives: Drug: Rocuronium (MB group) |
| Deep block (DB) group | Experimental | Not described Receives: Drug: Rocuronium (DB group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total infused dose of propofol
Measured: At 1 min after the anesthesia is finished
Secondary outcomes (1)
Electromyographic index presented on the anesthetic depth monitoring system
Measured: Through study completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
- Investigators
- Hyo-Seok Na, Principal investigator, 82, Gumi 173
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575443
- Sponsor's protocol ID
- ADMS NMD depth
- Status last verified
- Oct 2018
- First submitted
- 6 Oct 2015
- Last updated
- 26 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Block and Anesthetic Depth Monitoring
- ClinicalTrials.gov ID
- NCT02575443
- Acronym / sponsor ID
- ADMS NMD depth
- Conditions
- Cholecystectomy, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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.
The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate block (MB) group | Experimental | Drug: Rocuronium (MB group) |
| Deep block (DB) group | Experimental | Drug: Rocuronium (DB group) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gall bladder disease
- American Society of Anesthesiologist physical status 1 or 2
Key exclusion criteria (5 listed)
- Pregnancy
- Body mass index < 16
- Body mass index >30
- Neuromuscular disease
- Previous intraabdominal surgery
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 (MB group)Count of train-of-four: 1-2 Titration of rocuronium dose | Drug | Moderate block (MB) group |
| Rocuronium (DB group)Post-tetanic count: 1-2 Titration of rocuronium dose | Drug | Deep block (DB) group |
Primary outcome
Total infused dose of propofol
Time frame: At 1 min after the anesthesia is finished
1 secondary outcome
Electromyographic index presented on the anesthetic depth monitoring system
Time frame: Through study completion, an average of 2 hours
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 26 Oct 2018.
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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.
Hyo-Seok Na principal investigator
82, Gumi 173
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium (MB group) and Rocuronium (DB group) in people with Cholecystectomy, Laparoscopic, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 5 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 26 Oct 2018. 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 South Korea. 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.
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?
Total infused dose of propofol (time frame: At 1 min after the anesthesia is finished). 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 26 Oct 2018.