Postoperative ComplicationsNCT03174223
Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates
An observational study of Postoperative Complications and Postoperative Wound Infection, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Postoperative Wound Infection, Pneumonia
- What is being tested?
- deep neuromuscular block
- How many people
- 460 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to 1 Jul 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for laparoscopic abdominal surgery, eye surgery or neuro radiologic intervention surgery under general anesthesia
Who may be able to join
- deep neuromuscular block
- moderate neuromuscular block
- general anesthesia
- complete anesthesia chart
Who cannot join
- incomplete anesthesia chart
- missing data regarding postoperative complications or readmission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates: A Retrospective Analysis of Patient Chart Data
Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. In the leiden university medical center, deep NMB is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. This retrospective study intends to investigate whether the application of deep NMB for these procedures affects patient outcome and readmission rates.
- Being tested
- deep neuromuscular block
- Medical subject headings
- Postoperative Complications, Surgical Wound Infection, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep neuromuscular blockDrug
a continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular block | patients received a continuous rocuronium dose to maintain a depth of neuromuscular block of 1-2 twitches post tetanic count Receives: Drug: deep neuromuscular block | |
| moderate neuromuscular block | patients received neuromuscular block aimed at > 0 twitches train of four |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
readmission to the hospital
Measured: 30 days after surgery
Secondary outcomes (1)
Cost
The total cost, including sugammadex use and readmission cost
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174223
- Sponsor's protocol ID
- p17.031
- Status last verified
- Sep 2019
- First submitted
- 30 May 2017
- Last updated
- 17 Sep 2019
- 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 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates: A Retrospective Analysis of Patient Chart Data
- ClinicalTrials.gov ID
- NCT03174223
- Acronym / sponsor ID
- p17.031
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 2 Jun 2017 (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.
Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. In the leiden university medical center, deep NMB is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. This retrospective study intends to investigate whether the application of deep NMB for these procedures affects patient outcome and readmission rates.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular block | – | Drug: deep neuromuscular blockpatients received a continuous rocuronium dose to maintain a depth of neuromuscular block of 1-2 twitches post tetanic count |
| moderate neuromuscular block | – | –patients received neuromuscular block aimed at > 0 twitches train of four |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for laparoscopic abdominal surgery, eye surgery or neuro radiologic intervention surgery under general anesthesia
Key inclusion criteria (4 listed)
- deep neuromuscular block
- moderate neuromuscular block
- general anesthesia
- complete anesthesia chart
Key exclusion criteria (2 listed)
- incomplete anesthesia chart
- missing data regarding postoperative complications or readmission
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 |
|---|---|---|
| deep neuromuscular blocka continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count | Drug | Deep neuromuscular block |
Primary outcome
Readmission
Time frame: 30 days after surgery
readmission to the hospital
1 secondary outcome
Cost
Time frame: 30 days after surgery
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 17 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Postoperative Wound Infection, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 2 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 17 Sep 2019. 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 Netherlands. 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?
Readmission (time frame: 30 days after surgery). 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 17 Sep 2019.