Neuromuscular BlockadePhase 3NCT00535496

Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)

A Phase 3 study testing sugammadex in people with Neuromuscular Blockade, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Neuromuscular Blockade
What is being tested?: sugammadex
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: No sites listed yet
Study dates: Sep 2007to Feb 2008
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 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
between the ages of 18 to 64 years, inclusive
scheduled for a surgical procedure under general anesthesia requiring
neuromuscular relaxation with the use of rocuronium
scheduled for a surgical procedure in supine position
have given written informed consent

Who cannot join

participants with a difficult intubation because of expected anatomical
malformations
known or suspected to have neuromuscular disorders impairing
neuromuscular blockade and/or significant hepatic and/or renal
dysfunction
medical or physical condition that is expected to interfere

Show all 20Show fewer

with the proper conduct of simultaneous neuromuscular monitoring on
both arms
known or suspected to have a (family) history of malignant
hyperthermia
known or suspected to have arthritis or another disease that will
cause the thumb not to move freely
known or suspected to have an allergy to narcotics, muscle
relaxants or other medication used during general anesthesia
is receiving medication in a dose and/or at a time point known to
interfere with neuromuscular blocking agents (NMBAs), such as antibiotics, anticonvulsants and Mg2+
already participated in a sugammadex trial
participated in another clinical trial, not pre-approved, within prior 30 days
pregnant females
breast-feeding females

About this study

Official title: Comparison of the T4/T1 Ratio Measured by Means of the TOF Watch® SX With the Reappearance of T4 Measured by Means of a Peripheral Nerve Stimulator in Adult Subjects Receiving 4.0 mg.Kg-1 Sugammadex at 15 Minutes After Rocuronium

The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last maintenance dose of 0.15 mg/kg rocuronium.

Read the detailed description

The TOF-Watch® SX has been used for neuromuscular monitoring in all

clinical trials with sugammadex. In clinical practice however, a PNS is commonly

used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. In this trial, the relationship between the time to reappearance of T4 using PNS (i.e. Ministim® model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX was determined after a dose of 4.0 mg/kg sugammadex was administered 15 minutes after the last dose of rocuronium. Determining this relationship will enable the provision of advice on when it is safe to extubate participants after administration of 4.0 mg/kg sugammadex for reversing neuromuscular block while using a PNS. The time to reappearance of T4 was assessed by a blinded PNS-assessor. This assessor was blinded for the dose of sugammadex used and for the TOF results measured with the TOF-Watch® SX.

Conditions: Neuromuscular Blockade
Being tested: sugammadex

What participants receive

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

sugammadexDrug
Also called Org 25969, Bridion®, MK-8616, SCH 900616
Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

Study groups in NCT00535496
Study group	Role	What they receive
1	Experimental	sugammadex 1.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm) Receives: Drug: sugammadex
2	Experimental	sugammadex 1.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm) Receives: Drug: sugammadex
3	Experimental	sugammadex 4.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm) Receives: Drug: sugammadex
4	Experimental	sugammadex 4.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm) Receives: Drug: sugammadex

What is being measured

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

Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Measured: Up to 4 minutes after administering sugammadex
Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)
Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Measured: up to 2 minutes after administering sugammadex
Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex
The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Measured: Up to 3 minutes after administering sugammadex

Timeline

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

Sep 2007Feb 2008

First posted26 Sep 2007 (estimated)
Study startSep 2007
Primary completionJan 2008
Study completionFeb 2008

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 (1)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 Merck Sharp & Dohme LLCThe 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: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00535496
Sponsor's protocol ID: P05698
Other IDs: 19.4.313
Status last verified: Feb 2015
First submitted: 25 Sep 2007
Last updated: 17 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Drobnik L, Sparr HJ, Thorn SE, Khuenl-Brady KS, Rietbergen H, Prins ME, Ullman J. A randomized simultaneous comparison of acceleromyography with a peripheral nerve stimulator for assessing reversal of rocuronium-induced neuromuscular blockade with sugammadex. Eur J Anaesthesiol. 2010 Oct;27(10):866-73. doi: 10.1097/EJA.0b013e32833b1b85.
PubMed 20523215

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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RecruitingPhase 4
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
Post Operative Pulmonary Complications, Neuromuscular Blockade
Recruiting
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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the T4/T1 Ratio Measured by Means of the TOF Watch® SX With the Reappearance of T4 Measured by Means of a Peripheral Nerve Stimulator in Adult Subjects Receiving 4.0 mg.Kg-1 Sugammadex at 15 Minutes After Rocuronium
ClinicalTrials.gov ID: NCT00535496
Acronym / sponsor ID: P05698
Conditions: Neuromuscular Blockade
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jan 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 26 Sep 2007 (estimated)
Results: Posted 2 Sep 2013

Clinical summary

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

Detailed description

The TOF-Watch® SX has been used for neuromuscular monitoring in all

clinical trials with sugammadex. In clinical practice however, a PNS is commonly

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: sugammadexsugammadex 1.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm)
2	Experimental	Drug: sugammadexsugammadex 1.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm)
3	Experimental	Drug: sugammadexsugammadex 4.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm)
4	Experimental	Drug: sugammadexsugammadex 4.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm)

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
between the ages of 18 to 64 years, inclusive
scheduled for a surgical procedure under general anesthesia requiring
neuromuscular relaxation with the use of rocuronium
scheduled for a surgical procedure in supine position

Key exclusion criteria (20 listed)

participants with a difficult intubation because of expected anatomical
malformations
known or suspected to have neuromuscular disorders impairing
neuromuscular blockade and/or significant hepatic and/or renal
dysfunction

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: Org 25969, Bridion®, MK-8616, SCH 900616Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.	Drug	1, 2, 3, 4

Primary outcome

Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX
Time frame: Up to 4 minutes after administering sugammadex
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)
Time frame: up to 2 minutes after administering sugammadex
Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex
Time frame: Up to 3 minutes after administering sugammadex
The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.

Results and safety

Results posted to the registry on 2 Sep 2013, 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 1.0 mg/kg, TOF-Watch® SX Dominant Arm	15	15
Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm	15	13
Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm	30	30
Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm	31	31

Primary outcome: Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX

Time frame: Up to 4 minutes after administering sugammadex. Mean (Standard Deviation). Unit: Minutes

Measure	Sugammadex 4.0 mg/kg n = 60
Value	1.5 (0.7)

Population analysed: The Intent-To-Treat (ITT) population: randomized, received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed.The 1.0 mg/kg group was not evaluated.

Primary outcome: Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)

Time frame: up to 2 minutes after administering sugammadex. Mean (Standard Deviation). Unit: Minutes

Measure	Sugammadex 4.0 mg/kg n = 61
Value	0.8 (0.3)

Population analysed: The ITT population consisting of all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 1.0 mg/kg were not evaluated for this outcome measure.

Primary outcome: Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex

Time frame: Up to 3 minutes after administering sugammadex. Mean (95% Confidence Interval). Unit: Minutes

Measure	Sugammadex 4.0 mg/kg n = 60
Value	0.8 (0.6)

Population analysed: The ITT population: all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias; their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed. The 1.0 mg/kg group was not evaluated.

Adverse events

Time frame: From screening period up to and including seventh post-operative day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex 1.0 mg/kg	0 of 29 (0%)	24 of 29 (82.8%)	Not reported
Sugammadex 4.0 mg/kg	3 of 61 (4.9%)	53 of 61 (86.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20523215Drobnik L, Sparr HJ, Thorn SE, Khuenl-Brady KS, Rietbergen H, Prins ME, Ullman J. A randomized simultaneous comparison of acceleromyography with a peripheral nerve stimulator for assessing reversal of rocuronium-induced neuromuscular blockade with sugammadex. Eur J Anaesthesiol. 2010 Oct;27(10):866-73. doi: 10.1097/EJA.0b013e32833b1b85.

Related trials for Neuromuscular Blockade

Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruiting
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Not yet recruitingPhase 4
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RecruitingPhase 4
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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.

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 3 study testing sugammadex in people with Neuromuscular Blockade, run by Merck Sharp & Dohme LLC.

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 20 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 17 Mar 2015. 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 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 2 Sep 2013). 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?

Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX (time frame: Up to 4 minutes after administering sugammadex). 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 NCT00535496, which also lists 1 linked publication.

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 17 Mar 2015.