Neuromuscular BlockadePhase 4NCT02860507

Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

A Phase 4 study testing sugammadex, Neostigmine and Glycopyrrolate in people with Neuromuscular Blockade, run by University of South Florida.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuromuscular Blockade
What is being tested?: sugammadex, Neostigmine and Glycopyrrolate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Aug 2016to Feb 2018
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

Patients scheduled for open ventral hernia repair or open colectomy
ASA class I-III
18 years and older
Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg
Subjects who have given written informed consent

Who cannot join

Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1
Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;
Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients

Show all 9Show fewer

Subjects who have a contraindication to, Rocuronium or Sugammadex
Female subjects who are pregnant
Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg

About this study

Official title: A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Read the detailed description

Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.

Conditions: Neuromuscular Blockade
Being tested: sugammadex, Neostigmine, Glycopyrrolate

What participants receive

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

sugammadexDrug
Also called Bridion
NeostigmineDrug
GlycopyrrolateDrug

Study groups in NCT02860507
Study group	Role	What they receive
Neostigmine + Glycopyrrolate	Active comparator	Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv Receives: Drug: Neostigmine; Drug: Glycopyrrolate
sugammadex	Experimental	Sugammadex 4mg/kg Receives: Drug: sugammadex

What is being measured

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

Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
Measured: through start of next surgery, average of 2 hours

Secondary outcomes (1)

Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
Measured: through discharge from hospital, average of 72 hours

Timeline

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

Aug 2016Feb 2018

First posted9 Aug 2016 (estimated)
Study startAug 2016
Primary completionFeb 2018
Study completionFeb 2018

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.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
More trials run by University of South FloridaThe 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
Model description: Prospective Randomized Double Blinded
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02860507
Sponsor's protocol ID: TGH015
Status last verified: Apr 2019
First submitted: 2 Aug 2016
Last updated: 12 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Publications

Turner DA, Smith G. Evaluation of the combined effects of atropine and neostigmine on the lower oesophageal sphincter. Br J Anaesth. 1985 Oct;57(10):956-9. doi: 10.1093/bja/57.10.956.
PubMed 4041322
Proakis AG, Harris GB. Comparative penetration of glycopyrrolate and atropine across the blood--brain and placental barriers in anesthetized dogs. Anesthesiology. 1978 May;48(5):339-44. doi: 10.1097/00000542-197805000-00007. No abstract available.
PubMed 646152
Chhibber AK, Lustik SJ, Thakur R, Francisco DR, Fickling KB. Effects of anticholinergics on postoperative vomiting, recovery, and hospital stay in children undergoing tonsillectomy with or without adenoidectomy. Anesthesiology. 1999 Mar;90(3):697-700. doi: 10.1097/00000542-199903000-00010.
PubMed 10078669
Tramer MR, Fuchs-Buder T. Omitting antagonism of neuromuscular block: effect on postoperative nausea and vomiting and risk of residual paralysis. A systematic review. Br J Anaesth. 1999 Mar;82(3):379-86. doi: 10.1093/bja/82.3.379.
PubMed 10434820
Cheng CR, Sessler DI, Apfel CC. Does neostigmine administration produce a clinically important increase in postoperative nausea and vomiting? Anesth Analg. 2005 Nov;101(5):1349-1355. doi: 10.1213/01.ANE.0000180992.76743.C9.
PubMed 16243993
Naguib M, Brull SJ. Update on neuromuscular pharmacology. Curr Opin Anaesthesiol. 2009 Aug;22(4):483-90. doi: 10.1097/ACO.0b013e32832b8cff.
PubMed 19384229
Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
PubMed 18648227
Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
PubMed 19194156
Hemmerling TM, Zaouter C, Geldner G, Nauheimer D. Sugammadex--a short review and clinical recommendations for the cardiac anesthesiologist. Ann Card Anaesth. 2010 Sep-Dec;13(3):206-16. doi: 10.4103/0971-9784.69052.
PubMed 20826961
Abad-Gurumeta A, Ripolles-Melchor J, Casans-Frances R, Espinosa A, Martinez-Hurtado E, Fernandez-Perez C, Ramirez JM, Lopez-Timoneda F, Calvo-Vecino JM; Evidence Anaesthesia Review Group. A systematic review of sugammadex vs neostigmine for reversal of neuromuscular blockade. Anaesthesia. 2015 Dec;70(12):1441-52. doi: 10.1111/anae.13277.
PubMed 26558858
Koyuncu O, Turhanoglu S, Ozbakis Akkurt C, Karcioglu M, Ozkan M, Ozer C, Sessler DI, Turan A. Comparison of sugammadex and conventional reversal on postoperative nausea and vomiting: a randomized, blinded trial. J Clin Anesth. 2015 Feb;27(1):51-6. doi: 10.1016/j.jclinane.2014.08.010. Epub 2014 Dec 24.
PubMed 25544263
Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
PubMed 25225821
Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PubMed 18635478
Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.
PubMed 19417617
Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Intraoperative acceleromyographic monitoring reduces the risk of residual neuromuscular blockade and adverse respiratory events in the postanesthesia care unit. Anesthesiology. 2008 Sep;109(3):389-98. doi: 10.1097/ALN.0b013e318182af3b.
PubMed 18719436

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?

Official record

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Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
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Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
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Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
RecruitingPhase 4
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
Post Operative Pulmonary Complications, Neuromuscular Blockade

All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency
ClinicalTrials.gov ID: NCT02860507
Acronym / sponsor ID: TGH015
Conditions: Neuromuscular Blockade
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of South FloridaUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Aug 2016 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Feb 2018 (actual)
First posted: 9 Aug 2016 (estimated)
Results: Posted 12 Apr 2019

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 evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Detailed description

Study design

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

Arm	Type	Receives
Neostigmine + Glycopyrrolate	Active comparator	Drug: Neostigmine, Drug: GlycopyrrolateNeostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
sugammadex	Experimental	Drug: sugammadexSugammadex 4mg/kg

Who may qualify

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

Key inclusion criteria (5 listed)

Patients scheduled for open ventral hernia repair or open colectomy
ASA class I-III
18 years and older
Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg
Subjects who have given written informed consent

Key exclusion criteria (9 listed)

Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1
Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;

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
Neostigmine	Drug	Neostigmine + Glycopyrrolate
Glycopyrrolate	Drug	Neostigmine + Glycopyrrolate

Primary outcome

Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
Time frame: through start of next surgery, average of 2 hours

1 secondary outcome

Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
Time frame: through discharge from hospital, average of 72 hours

Results and safety

Results posted to the registry on 12 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neostigmine + Glycopyrrolate	25	25
Sugammadex	25	25

Primary outcome: Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.

Time frame: through start of next surgery, average of 2 hours. Mean (Standard Deviation). Unit: Minutes

Measure	Neostigmine + Glycopyrrolate n = 25	Sugammadex n = 25
Value	49.7 (16.18)	49.45 (16.67)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Two days: collecting informed consent, and surgery (3 hours).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neostigmine + Glycopyrrolate	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Sugammadex	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 4041322Turner DA, Smith G. Evaluation of the combined effects of atropine and neostigmine on the lower oesophageal sphincter. Br J Anaesth. 1985 Oct;57(10):956-9. doi: 10.1093/bja/57.10.956.
Background: PubMed 646152Proakis AG, Harris GB. Comparative penetration of glycopyrrolate and atropine across the blood--brain and placental barriers in anesthetized dogs. Anesthesiology. 1978 May;48(5):339-44. doi: 10.1097/00000542-197805000-00007. No abstract available.
Background: PubMed 10078669Chhibber AK, Lustik SJ, Thakur R, Francisco DR, Fickling KB. Effects of anticholinergics on postoperative vomiting, recovery, and hospital stay in children undergoing tonsillectomy with or without adenoidectomy. Anesthesiology. 1999 Mar;90(3):697-700. doi: 10.1097/00000542-199903000-00010.
Background: PubMed 10434820Tramer MR, Fuchs-Buder T. Omitting antagonism of neuromuscular block: effect on postoperative nausea and vomiting and risk of residual paralysis. A systematic review. Br J Anaesth. 1999 Mar;82(3):379-86. doi: 10.1093/bja/82.3.379.
Background: PubMed 16243993Cheng CR, Sessler DI, Apfel CC. Does neostigmine administration produce a clinically important increase in postoperative nausea and vomiting? Anesth Analg. 2005 Nov;101(5):1349-1355. doi: 10.1213/01.ANE.0000180992.76743.C9.
Background: PubMed 19384229Naguib M, Brull SJ. Update on neuromuscular pharmacology. Curr Opin Anaesthesiol. 2009 Aug;22(4):483-90. doi: 10.1097/ACO.0b013e32832b8cff.
Background: PubMed 18648227Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
Background: PubMed 19194156Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
Background: PubMed 20826961Hemmerling TM, Zaouter C, Geldner G, Nauheimer D. Sugammadex--a short review and clinical recommendations for the cardiac anesthesiologist. Ann Card Anaesth. 2010 Sep-Dec;13(3):206-16. doi: 10.4103/0971-9784.69052.
Background: PubMed 26558858Abad-Gurumeta A, Ripolles-Melchor J, Casans-Frances R, Espinosa A, Martinez-Hurtado E, Fernandez-Perez C, Ramirez JM, Lopez-Timoneda F, Calvo-Vecino JM; Evidence Anaesthesia Review Group. A systematic review of sugammadex vs neostigmine for reversal of neuromuscular blockade. Anaesthesia. 2015 Dec;70(12):1441-52. doi: 10.1111/anae.13277.
Background: PubMed 25544263Koyuncu O, Turhanoglu S, Ozbakis Akkurt C, Karcioglu M, Ozkan M, Ozer C, Sessler DI, Turan A. Comparison of sugammadex and conventional reversal on postoperative nausea and vomiting: a randomized, blinded trial. J Clin Anesth. 2015 Feb;27(1):51-6. doi: 10.1016/j.jclinane.2014.08.010. Epub 2014 Dec 24.
Background: PubMed 25225821Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
Individual participant dataSharing planned: Yes

Related trials for Neuromuscular Blockade

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
RecruitingPhase 4
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
Post Operative Pulmonary Complications, Neuromuscular Blockade

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sugammadex, Neostigmine and Glycopyrrolate in people with Neuromuscular Blockade, run by University of South Florida.

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 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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 12 Apr 2019). 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?

Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate. (time frame: through start of next surgery, average of 2 hours). 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 NCT02860507, which also lists 17 linked publications.

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 12 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.