Neuromuscular BlockadePhase 2NCT03519854

Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

A Phase 2 study testing Sugammadex and Esmeron® 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, men only
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Sugammadex and Esmeron®
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: No sites listed yet
Study dates: 1 Dec 2002to 1 Jun 2003
Phase: Phase 2
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
Men only
No healthy volunteers
Adult

Who may be able to join

Participants of ASA class 1 to 2.
Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Who cannot join

Participants in whom a difficult intubation because of anatomical malformations is expected.
Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia.
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.
Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.
Participants who have already participated in this trial.
Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.

About this study

Official title: A Multi-center, Randomized, Assessor-blinded, Placebo Controlled, Phase II, Parallel Dose-finding Trial in Male Subjects of ASA 1-2 to Assess the Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 When Administered After 0.6 mg.Kg-1 Esmeron® at 3, 5 or 15 Minutes

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.

Conditions: Neuromuscular Blockade
Being tested: Placebo, Sugammadex, Esmeron®

What participants receive

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

PlaceboDrug
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).
SugammadexDrug
Also called Org 25969; MK-8616; Bridion®.
Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.
Esmeron®Drug
Also called Rocuronium bromide
Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Study groups in NCT03519854
Study group	Role	What they receive
Arm A. Placebo; given 3 minutes after Esmeron®	Placebo comparator	Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron®
Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm G. Placebo; given 5 minutes after Esmeron®	Placebo comparator	Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron®
Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm M. Placebo; given 15 minutes after Esmeron®	Placebo comparator	Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron®
Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®
Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron®

What is being measured

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

Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Measured: Up to 70 minutes following administration of study treatment

Secondary outcomes (7)

Mean Heart Rate at Baseline
Mean heart rate at baseline was assessed. Baseline heart rate was defined as the heart rate measured under stable anesthesia prior to administration of study treatment.
Measured: Up to 45 minutes prior to study treatment administration
Mean Heart Rate at 2 Minutes Following Administration of Study Treatment
Mean heart rate at 2 minutes following administration of study treatment was assessed.
Measured: 2 minutes following administration of study treatment
Mean Heart Rate at 30 Minutes Following Administration of Study Treatment
Mean heart rate at 30 minutes following administration of study treatment was assessed.
Measured: 30 minutes following administration of study treatment
Mean Corrected QT Interval (QTc) at Baseline
Mean QTc interval at baseline was assessed. Baseline QTc interval was defined as the QTc interval measured under stable anesthesia prior to administration of study treatment. The baseline QTc interval is corrected for participant heart rate at baseline prior to study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.
Measured: Up to 45 minutes prior to study treatment administration
Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment
Mean QTc interval at 2 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 2 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.
Measured: 2 minutes following administration of study treatment
Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment
Mean QTc interval at 30 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 30 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.
Measured: 30 minutes following administration of study treatment
Number of Participants Experiencing an Adverse Event
The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Measured: Up to 7 days following administration of study treatment

Timeline

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

1 Dec 20021 Jun 2003

First posted9 May 2018
Study start1 Dec 2002
Primary completion1 Jun 2003
Study completion1 Jun 2003

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03519854
Sponsor's protocol ID: P05940
Other IDs: MK-8616-020, 19.4.202
Status last verified: Mar 2019
First submitted: 8 May 2018
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Assessor-blinded, Placebo Controlled, Phase II, Parallel Dose-finding Trial in Male Subjects of ASA 1-2 to Assess the Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 When Administered After 0.6 mg.Kg-1 Esmeron® at 3, 5 or 15 Minutes
ClinicalTrials.gov ID: NCT03519854
Acronym / sponsor ID: P05940
Conditions: Neuromuscular Blockade
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Dec 2002 (actual)
Primary completion: 1 Jun 2003 (actual)
Study completion: 1 Jun 2003 (actual)
First posted: 9 May 2018 (actual)
Results: Posted 1 Feb 2019

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: Double blind (participant, outcomes assessor)
Number of arms: 18

Arm	Type	Receives
Arm A. Placebo; given 3 minutes after Esmeron®	Placebo comparator	Drug: Placebo, Drug: Esmeron®Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm G. Placebo; given 5 minutes after Esmeron®	Placebo comparator	Drug: Placebo, Drug: Esmeron®Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm M. Placebo; given 15 minutes after Esmeron®	Placebo comparator	Drug: Placebo, Drug: Esmeron®Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®	Experimental	Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Who may qualify

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

Key inclusion criteria (2 listed)

Participants of ASA class 1 to 2.
Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Key exclusion criteria (7 listed)

Participants in whom a difficult intubation because of anatomical malformations is expected.
Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia.
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.
Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.

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
Placebo0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).	Drug	Arm A. Placebo; given 3 minutes after Esmeron®, Arm G. Placebo; given 5 minutes after Esmeron®, Arm M. Placebo; given 15 minutes after Esmeron®
SugammadexAlso: Org 25969; MK-8616; Bridion®.Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.	Drug	Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®
Esmeron®Also: Rocuronium bromideEsmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.	Drug	Arm A. Placebo; given 3 minutes after Esmeron®, Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®, Arm G. Placebo; given 5 minutes after Esmeron®, Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®, Arm M. Placebo; given 15 minutes after Esmeron®, Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®, Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®

Primary outcome

Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Time frame: Up to 70 minutes following administration of study treatment
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

7 secondary outcomes

Mean Heart Rate at Baseline
Time frame: Up to 45 minutes prior to study treatment administration
Mean Heart Rate at 2 Minutes Following Administration of Study Treatment
Time frame: 2 minutes following administration of study treatment
Mean Heart Rate at 30 Minutes Following Administration of Study Treatment
Time frame: 30 minutes following administration of study treatment
Mean Corrected QT Interval (QTc) at Baseline
Time frame: Up to 45 minutes prior to study treatment administration
Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment
Time frame: 2 minutes following administration of study treatment
Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment
Time frame: 30 minutes following administration of study treatment
Number of Participants Experiencing an Adverse Event
Time frame: Up to 7 days following administration of study treatment

Results and safety

Results posted to the registry on 1 Feb 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
Arm A. Placebo; Given 3 Minutes After Esmeron®	4	4
Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron®	6	6
Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron®	5	4
Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron®	6	6
Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron®	6	6
Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron®	6	6
Arm G. Placebo; Given 5 Minutes After Esmeron®	3	3
Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron®	6	6
Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron®	6	6
Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron®	6	6
Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron®	6	6
Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron®	6	6
Arm M. Placebo; Given 15 Minutes After Esmeron®	3	3
Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron®	6	6
Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron®	6	6
Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron®	6	6
Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron®	6	6
Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®	6	6

Primary outcome: Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9

Time frame: Up to 70 minutes following administration of study treatment. Mean (Standard Deviation). Unit: minutes

Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n = 3	Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n = 6	Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n = 3	Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n = 6	Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n = 5	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n = 5	Arm G. Placebo; Given 5 Minutes After Esmeron® n = 3	Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® n = 6	Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® n = 6	Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® n = 6	Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® n = 6	Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® n = 6	Arm M. Placebo; Given 15 Minutes After Esmeron® n = 3	Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® n = 6	Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® n = 6	Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® n = 6	Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® n = 6	Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® n = 6
Value	52.05 (8.77)	22.73 (11.58)	4.93 (1.25)	6.25 (9.00)	1.85 (0.62)	1.83 (0.87)	51.67 (13.13)	27.35 (6.35)	8.88 (7.80)	2.28 (0.73)	2.13 (0.93)	1.45 (0.60)	35.58 (9.05)	6.53 (1.73)	2.73 (0.72)	2.05 (1.18)	2.08 (1.97)	1.35 (0.20)

Population analysed: Per protocol, includes all randomized participants receiving study treatment without major protocol violations, having data available for this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 days following administration of study treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A. Placebo; Given 3 Minutes After Esmeron	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Arm G. Placebo; Given 5 Minutes After Esmeron	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Arm M. Placebo; Given 15 Minutes After Esmeron	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sugammadex and Esmeron® 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 2 inclusion and 7 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 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 1 Feb 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?

Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 (time frame: Up to 70 minutes following administration of study treatment). 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 NCT03519854.

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 2 Apr 2019.