Anesthesia, GeneralPhase 3NCT00298831

Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

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 primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). 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: 224 participants
Where: No sites listed yet
Study dates: 27 Oct 2005to 22 May 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 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Who cannot join

Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
Participants taking medications known to interfere with neuromuscular blocking agents.
Participants who are of child-bearing potential, pregnant, and breast feeding

About this study

Official title: A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of a Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia

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
At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.
RocuroniumDrug
Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

Study groups in NCT00298831
Study group	Role	What they receive
Sugammadex	Experimental	Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered. 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 MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of MK-8616 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 approximately 30 minutes following administration of study treatment

Secondary outcomes (5)

Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7
Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.7 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 0.7 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 approximately 10 minutes following administration of study treatment
Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8
Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.8 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 0.8 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 approximately 15 minutes following administration of study treatment
Clinical Assessment of Recovery - Participant's Level of Consciousness
The quality of recovery was assessed by asking the participant 40 questions from a validated Quality of Recovery Questionnaire (QoR-40). Participants were assessed for level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation), if applicable, by asking their name, if they are aware of where they are, and what day it is. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.
Measured: Up to 24 hours
Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL)
5-second head lift test was assessment of the ability of the participant to lift the head for 5 seconds and was performed by a blinded safety assessor. Tests were repeated every 15 minutes until the participant could successfully perform the 5-second head-lift. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.
Measured: Up to 24 hours
Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW)
General muscle weakness check was assessed by the investigator. The assessment of general muscle weakness was based on a scale from 0-10, with 0 representing total paralysis, 1 signifying extreme impairment, 9 for close to no impairment, and 10 for normal muscle strength. Scores of 3, 4, 5, etc. denoted increasing muscle strength in approximately 10% increments. Scores of 9 and lower were denoted as GMW. Assessment 1 occurred prior to transfer to the recovery room after extubation and assessment 2 occurred prior to discharge from the recovery room.
Measured: Up to 24 hours

Timeline

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

27 Oct 200522 May 2006

First posted3 Mar 2006 (estimated)
Study start27 Oct 2005
Primary completion22 May 2006
Study completion22 May 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00298831
Sponsor's protocol ID: P05943
Other IDs: 19.4.311, P05943, MK-8616-023
Status last verified: Mar 2019
First submitted: 1 Mar 2006
Last updated: 27 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hudson ME, Rietbergen H, Chelly JE. Sugammadex is effective in reversing rocuronium in the presence of antibiotics. BMC Anesthesiol. 2014 Aug 15;14:69. doi: 10.1186/1471-2253-14-69. eCollection 2014.
PubMed 25157214

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 Anesthesia, General trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of a Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia
ClinicalTrials.gov ID: NCT00298831
Acronym / sponsor ID: P05943
Conditions: Anesthesia, General
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Oct 2005 (actual)
Primary completion: 22 May 2006 (actual)
Study completion: 22 May 2006 (actual)
First posted: 3 Mar 2006 (estimated)
Results: Posted 15 Mar 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sugammadex	Experimental	Drug: Sugammadex, Drug: RocuroniumEach participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.

Who may qualify

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

Key inclusion criteria (1 listed)

American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Key exclusion criteria (3 listed)

Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
Participants taking medications known to interfere with neuromuscular blocking agents.
Participants who are of child-bearing potential, pregnant, and breast feeding

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-8616At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.	Drug	Sugammadex
RocuroniumEach participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.	Drug	Sugammadex

Primary outcome

Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9
Time frame: Up to approximately 30 minutes following administration of study treatment
Mean time from start of MK-8616 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).

5 secondary outcomes

Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7
Time frame: Up to approximately 10 minutes following administration of study treatment
Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8
Time frame: Up to approximately 15 minutes following administration of study treatment
Clinical Assessment of Recovery - Participant's Level of Consciousness
Time frame: Up to 24 hours
Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL)
Time frame: Up to 24 hours
Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW)
Time frame: Up to 24 hours

Results and safety

Results posted to the registry on 15 Mar 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
Sugammadex	224	192

Primary outcome: Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9

Time frame: Up to approximately 30 minutes following administration of study treatment. Mean (Standard Deviation). Unit: Minutes

Measure	Sugammadex n = 177
Value	2.32 (2.15)

Population analysed: The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.9 efficacy measurement.

5 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex	8 of 197 (4.1%)	187 of 197 (94.9%)	0 of 197

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25157214Hudson ME, Rietbergen H, Chelly JE. Sugammadex is effective in reversing rocuronium in the presence of antibiotics. BMC Anesthesiol. 2014 Aug 15;14:69. doi: 10.1186/1471-2253-14-69. eCollection 2014.
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 1 inclusion and 3 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 27 Mar 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 15 Mar 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 MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9 (time frame: Up to approximately 30 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 NCT00298831, 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 27 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.