Neuromuscular BlockadePhase 4NCT01933425

Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

A Phase 4 study testing rocuronium and sugammadex in people with Neuromuscular Blockade, run by Herlev Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Neuromuscular Blockade
What is being tested?: rocuronium and sugammadex
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteDenmark
Study dates: Aug 2013to Apr 2014
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

patients > 18 years old
elective laparoscopic operation
can read and understand Danish
informed consent

Who cannot join

BMI > 30 kg/cm2
known allergy to medications that are included in the project,
severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis),
neuromuscular disease that may interfere with neuromuscular data,
lactating or pregnant,
impaired liver function,

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converting to laparotomy,
perioperative use of neuromuscular blocking agents before randomization,
pneumoperitoneum set to >12 mmHg on the insufflator

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
Copenhagen, Søborg, 2830

Other trials in Denmark

About this study

Official title: Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Conditions: Neuromuscular Blockade
Being tested: rocuronium, sugammadex, placebo
Keywords: surgical conditions, laparoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rocuroniumDrug
sugammadexDrug
placeboDrug

Study groups in NCT01933425
Study group	Role	What they receive
Deep neuromuscular block followed by no neuromuscular block	Active comparator	Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade Receives: Drug: rocuronium; Drug: sugammadex; Drug: placebo
No neuromuscular block followed by deep neuromuscular block	Placebo comparator	No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade. Receives: Drug: rocuronium; Drug: sugammadex; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraabdominal Distance (Centimeters)
Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).
Measured: 1 hour

Secondary outcomes (2)

Intraabdominal Distance (Centimeters)
Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).
Measured: 1 hour
Surgical Conditions During Suturing of the Abdominal Fascia
Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Apr 2014

First posted2 Sep 2013 (estimated)
Study startAug 2013
Primary completionApr 2014
Study completionApr 2014

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 Neuromuscular BlockadeStudies 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: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01933425
Sponsor's protocol ID: NMBDK2013
Other IDs: 2013-001164-29
Status last verified: Mar 2015
First submitted: 28 Aug 2013
Last updated: 30 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)
ClinicalTrials.gov ID: NCT01933425
Acronym / sponsor ID: NMBDK2013
Conditions: Neuromuscular Blockade
Keywords: surgical conditions, laparoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Herlev HospitalUniversity, hospital or other
Study start: Aug 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 2 Sep 2013 (estimated)
Results: Posted 30 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Deep neuromuscular block followed by no neuromuscular block	Active comparator	Drug: rocuronium, Drug: sugammadex, Drug: placeboDeep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
No neuromuscular block followed by deep neuromuscular block	Placebo comparator	Drug: rocuronium, Drug: sugammadex, Drug: placeboNo neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

patients > 18 years old
elective laparoscopic operation
can read and understand Danish
informed consent

Key exclusion criteria (9 listed)

BMI > 30 kg/cm2
known allergy to medications that are included in the project,
severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis),
neuromuscular disease that may interfere with neuromuscular data,
lactating or pregnant,

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 followed by no neuromuscular block, No neuromuscular block followed by deep neuromuscular block
sugammadex	Drug	Deep neuromuscular block followed by no neuromuscular block, No neuromuscular block followed by deep neuromuscular block
placebo	Drug	Deep neuromuscular block followed by no neuromuscular block, No neuromuscular block followed by deep neuromuscular block

Primary outcome

Intraabdominal Distance (Centimeters)
Time frame: 1 hour
Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).

2 secondary outcomes

Intraabdominal Distance (Centimeters)
Time frame: 1 hour
Surgical Conditions During Suturing of the Abdominal Fascia
Time frame: 1 hour

Results and safety

Results posted to the registry on 30 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deep Neuromuscular Block First Then no Neuromuscular Block	7	7
No Neuromuscular Block First Then Deep Neuromuscular Block	7	7

Primary outcome: Intraabdominal Distance (Centimeters)

Time frame: 1 hour. Median (Full Range). Unit: centimeters

Measure	Deep Neuromuscular Block n = 14	No Neuromuscular Block n = 14
Value	9.3 (8.6 to 9.6)	9.0 (8.2 to 9.5)

Deep Neuromuscular Block vs No Neuromuscular Block: Mean Difference (Final Values): 0.33 (95% CI 0.07 to 0.59), p <0.05, t-test, 2 sided

Population analysed: Comparisons of changes in distances were performed with paired t-test.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deep Neuromuscular Block First Then no Neuromuscular Block	0 of 7 (0%)	0 of 7 (0%)	Not reported
No Neuromuscular Block First Then Deep Neuromuscular Block	0 of 7 (0%)	0 of 7 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
Not yet recruitingObservational study
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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.

Matias Vested Madsen, MD principal investigator

Department of Anesthesiology Herlev Hospital

Olav Istre, MD, DMSc, professor study director

Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen

1 site 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 and sugammadex in people with Neuromuscular Blockade, run by Herlev Hospital at 1 site in Denmark.

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 9 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 30 Mar 2015. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 30 Mar 2015). 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?

Intraabdominal Distance (Centimeters) (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01933425.

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 30 Mar 2015.