Incomplete Reversal of Neuromuscular BlockPhase 4NCT02909439

Quality of Recovery After Reversal With Neostigmine or Sugammadex.

A Phase 4 study testing Sugammadex and Neostigmine in people with Incomplete Reversal of Neuromuscular Block, run by Stony Brook University at 1 site in United States.

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

This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Incomplete Reversal of Neuromuscular Block
What is being tested?: Sugammadex and Neostigmine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Nov 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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be willing and able to provide written informed consent for the study
Participant must be greater than or equal to 18 years of age
Participant must be ASA (American Society of Anesthesiologists) class I, II or III
Planned use of neuromuscular blocking drugs
Planned use of endotracheal intubation
Planned for extubation to occur in the OR

Who cannot join

ASA (American Society of Anesthesiologists) Class IV
Age < 18 years old
Inability to give oral or written consent
Known or suspected neuromuscular disorder impairing neuromuscular function
True allergy to muscle relaxants
A (family) history of malignant hyperthermia

Show all 11Show fewer

A contraindication for neostigmine or sugammadex administration
Serum creatinine level of greater than 2.0 mg/dL
Surgery where the patient's arm is not available for neuromuscular monitoring
A plan to extubate under deep anesthesia
Pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Stony Brook University Hospital
Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: Pulmonary Function, Muscle Strength, Time to Extubation and Quality of Recovery in the Post Anesthesia Care Unit After Reversal of Neuromuscular Blockade With Neostigmine or Sugammadex.

Read the detailed description

Sugammadex has been shown to have a faster onset and more reliable reversal of neuromuscular blockade when compared to neostigmine as measured by return of Train-of-four (TOF) ratio to >0.9. (Breuckmann, 2015) The investigator's hypothesis is that sugammadex will be associated with improved deep breathing as measured by incentive spirometry in the PACU. The investigators also hypothesize that patients reversed with sugammadex will have shorter times to extubation and better recovery profiles in the PACU as measured by strength, PACU discharge readiness and quality of recovery scores.

Residual neuromuscular blockade after surgery can result in airway compromise, pulmonary complications, and possible need for reintubation and can be a negative experience for patients. Reintubation after surgery is currently a quality measure in NSQIP (National Surgery Quality Improvement Program) A TOF ratio of <0.9 has been identified as a marker of residual neuromuscular blockade in the PACU. (Farhan 2013) Several clinical trials have shown that reversal of neuromuscular blockade with sugammadex results in a faster and more reliable return to TOF ratio of >0.9 when compared to neostigmine. However most of these studies primarily report on TOF ratios. There are scant data on clinical outcomes after reversal with neostigmine versus sugammadex. Incentive spirometry is a clinically meaningful measurement of postoperative pulmonary function, i.e the ability to breath deeply, which minimizes atelectasis and risk of postoperative pneumonia.

The investigators will compare recovery profiles of patients who have received sugammadex or neostigmine for reversal of neuromuscular blockade after surgery. The primary outcome will be incentive spirometry volumes after surgery as a measure of pulmonary function. The secondary measures include hand grip measured using a dynamometer, time to extubation, time to PACU discharge, time to sit independently, and quality of recovery 15 survey scores.

This will be a single-center, prospective, randomized, assessor blinded, controlled trial. Patients will be randomized to either receive sugammadex or neostigmine for the reversal of neuromuscular blockade. The anesthesiologist will be unblinded to the study drug however the assessor in the PACU will be blinded.

Conditions: Incomplete Reversal of Neuromuscular Block
Being tested: Sugammadex, Neostigmine

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 given for reversal of neuromuscular blockade.
NeostigmineDrug
Also called Prostigmine
Neostigmine will be given for reversal of neuromuscular blockade.

Study groups in NCT02909439
Study group	Role	What they receive
Neostigmine	Active comparator	Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Receives: Drug: Neostigmine
Sugammadex	Active comparator	Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Receives: Drug: Sugammadex

What is being measured

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

Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Measured: 30 Minutes
Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Measured: 60 Minutes after reversal
Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Measured: 120 minutes after reversal

Secondary outcomes (7)

Grip Strength, Change From Baseline and Recovery Profile 30 Min
Grip strength will be measured with a hand dynamometer
Measured: 30 minutes
Grip Strength, Change From Baseline and Recovery Profile 60 Min
Grip strength will be measured with a hand dynamometer
Measured: 60 minutes after reversal
Grip Strength, Change From Baseline and Recovery Profile 120 Min
Grip strength will be measured with a hand dynamometer
Measured: 120 minutes after surgery
Time to Extubation
Measured time between surgery end and time of extubation (removal of breathing tube)
Measured: Immediately after surgery, up to 30 minutes
Train of Four Ratio > 90% During PACU Admission
Train of four ratio (TOFR) is the ration of the twitch height of the 4th twitch compared to the 1st twitch during train of four neuromuscular stimulation. This measurement was performed using a TOF Watch, which in an accelemyographer. Electric current is applied to the ulnar nevre and the twitches are measured in the thumb. Adequate reversal of neuromuscular blockade is defined as a TOFR >90%.
Measured: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
Quality of Recovery 15 Survey
15 question survey to assess patient's overall quality of recovery after anesthesia/surgery.
Quality of Recovery 15 Survey. Minimum: 0 Maximum: 150 Higher Scores mean a better outcome and better quality of recovery.
Part A: How have you been feeling in the last 24 hours? 0 = none of the time (poor), 10 = all of the time (excellent). Examples: able to breath easily, able to enjoy food, feeling rested. etc.
Part B: Have you had any of the following in the last 24 hours? 10 to 0, where 10 = none of the time (Excellent) and 0 = all of the time (poor). Examples: moderate pain, nausea or vomiting, feeling worried or anxious, etc.
Measured: Postoperative day number one
Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)
Measured time between PACU admission and meeting PACU discharge readiness. PACU discharge was defined as when the patient had an Aldrete score of 9 or higher as determined by the PACU nurse. The Aldrete score is a measure of post anesthesia recovery. 0 is poor condition and 10 is excellent condition. There are 5 assessment items (able to move voluntary, breathing, consciousness, circulation (BP) and spO2) which are graded on a 0-2 point scale with 0 being poor and 2 being excellent.
Measured: Within 4 hours from the end of surgery

Timeline

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

Nov 2016Feb 2018

First posted21 Sep 2016 (estimated)
Study startNov 2016
Primary completion9 Nov 2017
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 (3)Papers the sponsor has linked to this study.
Other trials for Incomplete Reversal of Neuromuscular BlockStudies 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: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02909439
Sponsor's protocol ID: 917402-3
Status last verified: May 2020
First submitted: 31 Aug 2016
Last updated: 22 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.
PubMed 25935840
Farhan H, Moreno-Duarte I, McLean D, Eikermann M. Residual Paralysis: Does it Influence Outcome After Ambulatory Surgery? Curr Anesthesiol Rep. 2014 Dec;4(4):290-302. doi: 10.1007/s40140-014-0073-6.
PubMed 25530723
Abola RE, Romeiser J, Rizwan S, Lung B, Gupta R, Bennett-Guerrero E. A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength. Can J Anaesth. 2020 Aug;67(8):959-969. doi: 10.1007/s12630-020-01695-4. Epub 2020 May 13.
PubMed 32405975

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pulmonary Function, Muscle Strength, Time to Extubation and Quality of Recovery in the Post Anesthesia Care Unit After Reversal of Neuromuscular Blockade With Neostigmine or Sugammadex.
ClinicalTrials.gov ID: NCT02909439
Acronym / sponsor ID: 917402-3
Conditions: Incomplete Reversal of Neuromuscular Block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Stony Brook UniversityUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Nov 2016
Primary completion: 9 Nov 2017 (actual)
Study completion: Feb 2018 (actual)
First posted: 21 Sep 2016 (estimated)
Results: Posted 22 May 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Neostigmine	Active comparator	Drug: NeostigminePatients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.
Sugammadex	Active comparator	Drug: SugammadexPatients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participant must be willing and able to provide written informed consent for the study
Participant must be greater than or equal to 18 years of age
Participant must be ASA (American Society of Anesthesiologists) class I, II or III
Planned use of neuromuscular blocking drugs
Planned use of endotracheal intubation

Key exclusion criteria (11 listed)

ASA (American Society of Anesthesiologists) Class IV
Age < 18 years old
Inability to give oral or written consent
Known or suspected neuromuscular disorder impairing neuromuscular function
True allergy to muscle relaxants

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 given for reversal of neuromuscular blockade.	Drug	Sugammadex
NeostigmineAlso: ProstigmineNeostigmine will be given for reversal of neuromuscular blockade.	Drug	Neostigmine

Primary outcome

Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
Time frame: 30 Minutes
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes
Time frame: 60 Minutes after reversal
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes
Time frame: 120 minutes after reversal
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

7 secondary outcomes

Grip Strength, Change From Baseline and Recovery Profile 30 Min
Time frame: 30 minutes
Grip Strength, Change From Baseline and Recovery Profile 60 Min
Time frame: 60 minutes after reversal
Grip Strength, Change From Baseline and Recovery Profile 120 Min
Time frame: 120 minutes after surgery
Time to Extubation
Time frame: Immediately after surgery, up to 30 minutes
Train of Four Ratio > 90% During PACU Admission
Time frame: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
Quality of Recovery 15 Survey
Time frame: Postoperative day number one
Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)
Time frame: Within 4 hours from the end of surgery

Results and safety

Results posted to the registry on 22 May 2020, 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	31	31
Sugammadex	31	31

Primary outcome: Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes

Time frame: 30 Minutes. Median (Inter-Quartile Range). Unit: mL

Measure	Neostigmine n = 21	Sugammadex n = 18
Value	-700 (-1650 to -250)	-862 (-1800 to -500)

Population analysed: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Primary outcome: Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes

Time frame: 60 Minutes after reversal. Median (Inter-Quartile Range). Unit: mL

Measure	Neostigmine n = 25	Sugammadex n = 29
Value	-500 (-1300 to -250)	-1150 (-1850 to -362.5)

Primary outcome: Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes

Time frame: 120 minutes after reversal. Median (Inter-Quartile Range). Unit: mL

Measure	Neostigmine n = 27	Sugammadex n = 27
Value	-400 (-1560 to -200)	-850 (-1500 to -100)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neostigmine	0 of 31 (0%)	2 of 31 (6.5%)	0 of 31
Sugammadex	0 of 31 (0%)	2 of 31 (6.5%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25935840Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.
Background: PubMed 25530723Farhan H, Moreno-Duarte I, McLean D, Eikermann M. Residual Paralysis: Does it Influence Outcome After Ambulatory Surgery? Curr Anesthesiol Rep. 2014 Dec;4(4):290-302. doi: 10.1007/s40140-014-0073-6.
Derived from this study: PubMed 32405975Abola RE, Romeiser J, Rizwan S, Lung B, Gupta R, Bennett-Guerrero E. A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength. Can J Anaesth. 2020 Aug;67(8):959-969. doi: 10.1007/s12630-020-01695-4. Epub 2020 May 13.
Individual participant dataSharing planned: No

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.

Ramon Abola, MD principal investigator

Stony Brook Medicine, Department of Anesthesiology

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 Incomplete Reversal of Neuromuscular Block, run by Stony Brook University at 1 site 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 6 inclusion and 11 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 22 May 2020. 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 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 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 22 May 2020). 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?

Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes (time frame: 30 Minutes). The study lists 3 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 NCT02909439, which also lists 3 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 22 May 2020.