Postoperative Respiratory ConditionPhase 4NeuropaNCT02243943
Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile
A Phase 4 study testing Sugammadex and Neostigmine in people with Postoperative Respiratory Condition, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Condition
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to 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
- Age 18 years
- - BMI < 35
- -ASA class I- III
- -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's
- Patients with ability to give oral and written informed consent
Who cannot join
- Failure to meet the inclusion criteria
- -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
- -Contraindications for the use of neostigmine
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- Intestinal obstruction,
- COPD GOLD 4
- -Abnormal heart rhythm (eg. bradycardia: < 40/min);
- -Surgery requiring neuraxial anesthesia / analgesia
- -Preoperative cognitive dysfunction or mental disabilities
- -Preexistent significant pulmonary disease with preoperative SpO2 < 90%
- -Preoperative ICU treatment / intubation (ICU patient);
- -Need for postoperative ICU treatment or ventilation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.
- Conditions
- Postoperative Respiratory Condition
- Being tested
- Sugammadex, Neostigmine
- Keywords
- Neuromuscular block, neuromuscular reversal, postoperative conditions, respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
NeostigmineDrug
Also called Prostigmin
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Receives: Drug: Sugammadex |
| neostigmine | Active comparator | subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Lowest Saturation
Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery
Measured: 45 minutes post surgery
Secondary outcomes (2)
Pain
using the 1-10 numeric rating scale
Measured: 45 minutes post surgery
Sedation
using the Leiden observer alertness score (1 alert - 5 sedated)
Measured: 45 minutes post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- 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 Postoperative Respiratory ConditionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
- Investigators
- Albert Dahan, MD, PhD, Professor, Principal investigator, Leiden Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243943
- Sponsor's protocol ID
- NL34186.058.10
- Other IDs
- NL34186.058.10
- Acronym
- Neuropa
- Status last verified
- Dec 2016
- First submitted
- 12 Sep 2014
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT02243943
- Acronym / sponsor ID
- Neuropa / NL34186.058.10
- Conditions
- Postoperative Respiratory Condition
- Keywords
- Neuromuscular block, neuromuscular reversal, postoperative conditions, respiratory failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Posted 25 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: SugammadexSubjects in this arm will be reversed with sugammadex 2-4 mg/kg |
| neostigmine | Active comparator | Drug: Neostigminesubjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years
- - BMI < 35
- -ASA class I- III
- -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's
Key exclusion criteria (14 listed)
- Failure to meet the inclusion criteria
- A (family) history of malignant hyperthermia
- Intestinal obstruction,
- COPD GOLD 4
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 |
|---|---|---|
| SugammadexAlso: Bridion | Drug | Sugammadex |
| NeostigmineAlso: Prostigmin | Drug | neostigmine |
Primary outcome
Mean Lowest Saturation
Time frame: 45 minutes post surgery
Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery
2 secondary outcomes
Pain
Time frame: 45 minutes post surgery
Sedation
Time frame: 45 minutes post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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
Leiden Medical University
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 Sugammadex and Neostigmine in people with Postoperative Respiratory Condition, 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 5 inclusion and 14 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 6 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 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.
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 25 Aug 2016). 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?
Mean Lowest Saturation (time frame: 45 minutes post 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 6 Feb 2017.