SurgeryPhase 3NCT03116997
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
A Phase 3 study testing Neostigmine+glycopyrrolate and Sugammadex in people with Surgery, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Neostigmine+glycopyrrolate and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Apr 2017to 3 Mar 2022
- Phase
- Phase 3
- 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
- Adult patients age 18 years of age or greater who are capable of giving consent
- Undergoing surgical procedures of expected length 6 </= hours requiring NMB
Who cannot join
- Pregnancy
- History of documented anaphylaxis or contraindication to any of the study medications
- Active coronary disease with a positive cardiac stress test
- History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 < 50% of predicted
- Serum Creatinine >/= 2.0 mg/dL
- Severe hepatic dysfunction accompanied by coagulopathy
Show all 16Show fewer
- Definition:
- Known liver Disease AND
- INR > 1.5 (except for patients on anticoagulants) AND
- Platelet count <100,00/ul without other obvious cause
- Chronic sustained release opioid for > 2 weeks duration pre op (in the 30 days prior to surgery)
- Use of toremifene
- Significant cognitive impairment or documented psychologic impairment
- Myasthenia gravis or other neuromuscular disease
- Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation.
- American Society of Anesthesiologists (ASA) Status > 3
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memoral Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Randomized Controlled Assessor Blinded Clinical Trial of Sugammadex Versus Neostigmine /Glycopyrrolate for Reversal of Rocuronium Induced Neuromuscular Blockade: Time to Discharge From Post Anesthesia Care Unit and Patient Satisfaction With Recovery
The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.
- Conditions
- Surgery
- Being tested
- Neostigmine+glycopyrrolate, Sugammadex
- Keywords
- neuromuscular blockade, sugammadex, SUG, neostigmine, NEO/GLYCO, 17-207
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine+glycopyrrolateDrug
At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
SugammadexDrug
At the conclusion of surgery neuromuscular blockade reversed with sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular blockade reversed with neostigmine/gly | Experimental | Not described Receives: Drug: Neostigmine+glycopyrrolate |
| Neuromuscular blockade reversed with sugammadex | Active comparator | Not described Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Participants' Recovery Time Post-Surgery
Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start7 Apr 2017
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
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 SurgeryStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- German Echeverry, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116997
- Sponsor's protocol ID
- 17-207
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2017
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Assessor Blinded Clinical Trial of Sugammadex Versus Neostigmine /Glycopyrrolate for Reversal of Rocuronium Induced Neuromuscular Blockade: Time to Discharge From Post Anesthesia Care Unit and Patient Satisfaction With Recovery
- ClinicalTrials.gov ID
- NCT03116997
- Acronym / sponsor ID
- 17-207
- Conditions
- Surgery
- Keywords
- neuromuscular blockade, sugammadex, SUG, neostigmine, NEO/GLYCO, 17-207
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular blockade reversed with neostigmine/gly | Experimental | Drug: Neostigmine+glycopyrrolate |
| Neuromuscular blockade reversed with sugammadex | Active comparator | Drug: Sugammadex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients age 18 years of age or greater who are capable of giving consent
- Undergoing surgical procedures of expected length 6 </= hours requiring NMB
Key exclusion criteria (16 listed)
- Pregnancy
- History of documented anaphylaxis or contraindication to any of the study medications
- Active coronary disease with a positive cardiac stress test
- History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 < 50% of predicted
- Serum Creatinine >/= 2.0 mg/dL
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 |
|---|---|---|
| Neostigmine+glycopyrrolateAt the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate | Drug | Neuromuscular blockade reversed with neostigmine/gly |
| SugammadexAt the conclusion of surgery neuromuscular blockade reversed with sugammadex | Drug | Neuromuscular blockade reversed with sugammadex |
Primary outcome
Measure Participants' Recovery Time Post-Surgery
Time frame: 1 day
Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
German Echeverry, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neostigmine+glycopyrrolate and Sugammadex in people with Surgery, run by Memorial Sloan Kettering Cancer Center at 4 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 2 inclusion and 16 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Mar 2023). 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?
Measure Participants' Recovery Time Post-Surgery (time frame: 1 day). 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 18 May 2025.