Anesthesia, GeneralPhase 3NCT00475215

Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

A Phase 3 study testing Sugammadex and Rocuronium in people with Anesthesia, General, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anesthesia, General
What is being tested?: Sugammadex and Rocuronium
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: No sites listed yet
Study dates: 27 Oct 2005to 9 Sep 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

American Society of Anesthesiologists (ASA) Class 1 to 3;
Has been diagnosed with or having a past history of pulmonary disease;
Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
Is scheduled for surgery in supine position;
Has given written informed consent;

Who cannot join

Is expected to have a difficult intubation due to anatomical malformations;
Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
Has known or suspected of having a (family) history of malignant hyperthermia;
Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
Is a female who is pregnant or breast-feeding;

Show all 9Show fewer

Is a female of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence] or using only hormonal contraception as birth control;
Has already participated in a sugammadex trial including Protocol 19.4.308;
Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.

About this study

Official title: A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications

Conditions: Anesthesia, General
Being tested: Sugammadex, Rocuronium

What participants receive

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

SugammadexDrug
Also called Org 25969, MK-8616, Bridion®
Sugammadex solution for injection.
RocuroniumDrug
Also called Zemuron®
Rocuronium bromide solution for injection.

Study groups in NCT00475215
Study group	Role	What they receive
Rocuronium + Sugammadex 2.0 mg/kg	Experimental	After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg. Receives: Drug: Sugammadex; Drug: Rocuronium
Rocuronium + Sugammadex 4.0 mg/kg	Experimental	After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg. Receives: Drug: Sugammadex; Drug: Rocuronium

What is being measured

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

Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Measured: Up to 90 minutes
Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)
The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Up to 7 days
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Up to 7 days

Secondary outcomes (8)

Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Measured: Up to 90 minutes
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Measured: Up to 90 minutes
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.
Measured: Up to 6 hours (prior to transfer to the recovery room after extubation)
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room
The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.
Measured: Up to 6 hours (prior to discharge from the recovery room)
Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.
Measured: Up to 6 hours (prior to transfer to the recovery room after extubation)
Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room
The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.
Measured: Up to 6 hours (prior to discharge from the recovery room)
General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.
Measured: Up to 6 hours (prior to transfer to the recovery room after extubation)
General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room
Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.
Measured: Up to 6 hours (prior to discharge from the recovery room)

Timeline

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

27 Oct 20059 Sep 2006

First posted21 May 2007 (estimated)
Study start27 Oct 2005
Primary completion21 Aug 2006
Study completion9 Sep 2006

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 Anesthesia, GeneralStudies 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: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00475215
Sponsor's protocol ID: P05932
Other IDs: 19.4.308, P05932, MK-8616-017
Status last verified: Apr 2019
First submitted: 17 May 2007
Last updated: 12 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Amao R, Zornow MH, Cowan RM, Cheng DC, Morte JB, Allard MW. Use of sugammadex in patients with a history of pulmonary disease. J Clin Anesth. 2012 Jun;24(4):289-97. doi: 10.1016/j.jclinane.2011.09.006.
PubMed 22608583

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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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 Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications
ClinicalTrials.gov ID: NCT00475215
Acronym / sponsor ID: P05932
Conditions: Anesthesia, General
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Oct 2005 (actual)
Primary completion: 21 Aug 2006 (actual)
Study completion: 9 Sep 2006 (actual)
First posted: 21 May 2007 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rocuronium + Sugammadex 2.0 mg/kg	Experimental	Drug: Sugammadex, Drug: RocuroniumAfter the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg.
Rocuronium + Sugammadex 4.0 mg/kg	Experimental	Drug: Sugammadex, Drug: RocuroniumAfter the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/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)

American Society of Anesthesiologists (ASA) Class 1 to 3;
Has been diagnosed with or having a past history of pulmonary disease;
Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
Is scheduled for surgery in supine position;
Has given written informed consent;

Key exclusion criteria (9 listed)

Is expected to have a difficult intubation due to anatomical malformations;
Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
Has known or suspected of having a (family) history of malignant hyperthermia;
Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;

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, MK-8616, Bridion®Sugammadex solution for injection.	Drug	Rocuronium + Sugammadex 2.0 mg/kg, Rocuronium + Sugammadex 4.0 mg/kg
RocuroniumAlso: Zemuron®Rocuronium bromide solution for injection.	Drug	Rocuronium + Sugammadex 2.0 mg/kg, Rocuronium + Sugammadex 4.0 mg/kg

Primary outcome

Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease
Time frame: Up to 90 minutes
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)
Time frame: Up to 7 days
The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
Time frame: Up to 7 days
The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

8 secondary outcomes

Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease
Time frame: Up to 90 minutes
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease
Time frame: Up to 90 minutes
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Time frame: Up to 6 hours (prior to transfer to the recovery room after extubation)
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room
Time frame: Up to 6 hours (prior to discharge from the recovery room)
Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Time frame: Up to 6 hours (prior to transfer to the recovery room after extubation)
Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room
Time frame: Up to 6 hours (prior to discharge from the recovery room)
General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Time frame: Up to 6 hours (prior to transfer to the recovery room after extubation)
General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room
Time frame: Up to 6 hours (prior to discharge from the recovery room)

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
Rocuronium + Sugammadex 2.0 mg/kg	44	39
Rocuronium + Sugammadex 4.0 mg/kg	42	38

Primary outcome: Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease

Time frame: Up to 90 minutes. Mean (Standard Deviation). Unit: Minutes

Measure	Rocuronium + Sugammadex 2.0 mg/kg n = 33	Rocuronium + Sugammadex 4.0 mg/kg n = 33
Value	2.42 (1.93)	2.1 (1.8)

Population analysed: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 11 participants (2.0 mg/kg n=6 and 4.0 mg/kg n=5), data were missing due to watch malfunction (n=2), the data that was obtained was considered unreliable (n=6), or the watch was removed prior to recovery to 0.9 (n=3).

Primary outcome: Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)

Time frame: Up to 7 days. Number. Unit: Percentage of Participants

Measure	Rocuronium + Sugammadex 2.0 mg/kg n = 39	Rocuronium + Sugammadex 4.0 mg/kg n = 38
Value	97.4	94.7

Population analysed: All randomized participants who received sugammadex are included.

Primary outcome: Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)

Time frame: Up to 7 days. Number. Unit: Percentage of Participants

Measure	Rocuronium + Sugammadex 2.0 mg/kg n = 39	Rocuronium + Sugammadex 4.0 mg/kg n = 38
Value	0	0

Population analysed: All randomized participants who received sugammadex are included.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rocuronium + Sugammadex 2.0 mg	4 of 39 (10.3%)	38 of 39 (97.4%)	0 of 39
Rocuronium + Sugammadex 4.0 mg	3 of 38 (7.9%)	34 of 38 (89.5%)	0 of 38

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.
Derived from this study: PubMed 22608583Amao R, Zornow MH, Cowan RM, Cheng DC, Morte JB, Allard MW. Use of sugammadex in patients with a history of pulmonary disease. J Clin Anesth. 2012 Jun;24(4):289-97. doi: 10.1016/j.jclinane.2011.09.006.
Click here to access a synopsis of the study results.Link provided by the sponsor.

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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 3 study testing Sugammadex and Rocuronium in people with Anesthesia, General, 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 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 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 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?

Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease (time frame: Up to 90 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 NCT00475215, 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 12 Apr 2019.