General SurgeryPhase 4NCT02728726

Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

A Phase 4 study testing Sugammadex in people with General Surgery, run by Mayo Clinic at 2 sites in United States.

Completed

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

Trial summary

The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: General Surgery
What is being tested?: Sugammadex
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 260 participants
Where: 2 sitesUnited States
Study dates: Jun 2016to Dec 2019
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing surgery with general anesthesia
Patients weighing > or = 80 pounds
Patients not intubated prior to surgery
Patients who are able to give informed consent

Who cannot join

Patients unable to give informed consent.
Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
Patients who are anticipated to remain intubated in recovery period.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The University of Texas, UTHealth
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor

Conditions: General Surgery
Being tested: Sugammadex, Placebo
Keywords: Postoperative respiratory depression, Neuromuscular Agents

What participants receive

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

SugammadexDrug
Also called Bridion
Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
PlaceboDrug
Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

Study groups in NCT02728726
Study group	Role	What they receive
Sugammadex	Experimental	Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated. Receives: Drug: Sugammadex
Placebo	Placebo comparator	Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated. Receives: Drug: Placebo

What is being measured

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

Decreased Minute Ventilation (MV)
The number of subjects who have a MV as defined as [MV <80% MV predicted (MVPRED) based on Body Surface Area]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Measured: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
Decreased Average Minute Ventilation (MV)
The number of subjects who have an average MV <80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Measured: 15---30 minutes after Post-anesthesia care unit (PACU) arrival

Secondary outcomes (1)

Train of Four (TOF) Ratio
The number of subjects to have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)
Measured: upon PACU discharge, approximately 8 hours

Timeline

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

Jun 2016Dec 2019

First posted5 Apr 2016 (estimated)
Study startJun 2016
Primary completionDec 2019
Study completionDec 2019

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 General SurgeryStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02728726
Sponsor's protocol ID: 15-008685
Status last verified: Jun 2022
First submitted: 15 Mar 2016
Last updated: 14 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 General Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor
ClinicalTrials.gov ID: NCT02728726
Acronym / sponsor ID: 15-008685
Conditions: General Surgery
Keywords: Postoperative respiratory depression, Neuromuscular Agents
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, University of Texas, Respiratory Motion, Inc.
Study start: Jun 2016 (actual)
Primary completion: Dec 2019 (actual)
Study completion: Dec 2019 (actual)
First posted: 5 Apr 2016 (estimated)
Results: Posted 14 Jul 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sugammadex	Experimental	Drug: SugammadexSubjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.
Placebo	Placebo comparator	Drug: PlaceboSubjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients undergoing surgery with general anesthesia
Patients weighing > or = 80 pounds
Patients not intubated prior to surgery
Patients who are able to give informed consent

Key exclusion criteria (3 listed)

Patients unable to give informed consent.
Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
Patients who are anticipated to remain intubated in recovery period.

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: BridionSugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.	Drug	Sugammadex
PlaceboPlacebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.	Drug	Placebo

Primary outcome

Decreased Minute Ventilation (MV)
Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
The number of subjects who have a MV as defined as [MV <80% MV predicted (MVPRED) based on Body Surface Area]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Decreased Average Minute Ventilation (MV)
Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
The number of subjects who have an average MV <80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.

1 secondary outcome

Train of Four (TOF) Ratio
Time frame: upon PACU discharge, approximately 8 hours

Results and safety

Results posted to the registry on 14 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sugammadex	127	127
Placebo	133	133

Primary outcome: Decreased Minute Ventilation (MV)

Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival. Count of participants. Unit: Participants

Measure	Sugammadex n = 62	Placebo n = 54
Value	20	26

Primary outcome: Decreased Average Minute Ventilation (MV)

Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival. Count of participants. Unit: Participants

Measure	Sugammadex n = 62	Placebo n = 54
Value	20	26

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline to end of study (discharged from the recovery room), approximately 8 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex	0 of 127 (0%)	0 of 127 (0%)	0 of 127
Placebo	0 of 133 (0%)	2 of 133 (1.5%)	0 of 133

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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Head and Neck Cancer (H&N)

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.

J Ross Renew, MD principal investigator

Mayo Clinic

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 Sugammadex in people with General Surgery, run by Mayo Clinic at 2 sites in United States.

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 3 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 14 Jul 2022. 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 United States. 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 14 Jul 2022). 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?

Decreased Minute Ventilation (MV) (time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival). The study lists 2 primary outcomes in all. 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 NCT02728726.

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 14 Jul 2022.