Surgical ConditionsPhase 4BLISS3NCT02553629
Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients
A Phase 4 study testing Rocuronium in people with Surgical Conditions, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Conditions
- What is being tested?
- Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- ASA I-III
- BMI > 34 kg/m2
- Elective bariatric surgery.
Who cannot join
- Known or suspected neuromuscular disorders impairing neuromuscular function
- Allergies to muscle relaxants, anesthetics or narcotics
- A(family) history of malignant hyperthermia
- Women who are or may be pregnant or are currently breast feeding
- Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, South Holland
Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
The Hague, South Holland
About this study
Official title: Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.
- Conditions
- Surgical Conditions
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
| Study group | Role | What they receive |
|---|---|---|
| moderate neuromuscular block | Active comparator | rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Receives: Drug: Rocuronium |
| deep neuromuscular block | Experimental | rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Rating
During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.
The rating scale will be averaged for each subject and the mean values will be reported.
Measured: intraoperative
Secondary outcomes (4)
Extubation
The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).
Measured: intraoperative
Pain
pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.
Measured: postoperative, for up to 2 hours
Respiration
Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.
The data were averaged per subject and the mean of the mean data are reported.
Measured: 2 hours postoperative
Mean Arterial Blood Pressure
Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.
The data will be averaged per subject and the mean of the mean values are reported.
Measured: 2 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical ConditionsStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Medical Center Haaglanden
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
- Investigators
- Albert Dahan, MD, PhD, professor, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553629
- Sponsor's protocol ID
- NL52829.058.15
- Acronym
- BLISS3
- Status last verified
- Dec 2016
- First submitted
- 28 Aug 2015
- Last updated
- 3 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02553629
- Acronym / sponsor ID
- BLISS3 / NL52829.058.15
- Conditions
- Surgical Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Medical Center Haaglanden
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 3 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate neuromuscular block | Active comparator | Drug: Rocuroniumrocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches |
| deep neuromuscular block | Experimental | Drug: Rocuroniumrocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- BMI > 34 kg/m2
- Elective bariatric surgery.
Key exclusion criteria (5 listed)
- Known or suspected neuromuscular disorders impairing neuromuscular function
- Allergies to muscle relaxants, anesthetics or narcotics
- A(family) history of malignant hyperthermia
- Women who are or may be pregnant or are currently breast feeding
- Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.
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 | Drug | deep neuromuscular block, moderate neuromuscular block |
Primary outcome
Surgical Rating
Time frame: intraoperative
During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported.
4 secondary outcomes
Extubation
Time frame: intraoperative
Pain
Time frame: postoperative, for up to 2 hours
Respiration
Time frame: 2 hours postoperative
Mean Arterial Blood Pressure
Time frame: 2 hours postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Albert Dahan, MD, PhD, professor principal investigator
LUMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium in people with Surgical Conditions, run by Leiden University Medical Center at 2 sites 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 3 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Surgical Rating (time frame: intraoperative). 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 3 Feb 2017.