Anesthesia, GeneralPhase 3NCT00559468
Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)
A Phase 3 study testing Sugammadex, Rocuronium and Sevoflurane in people with Anesthesia, General, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Sugammadex, Rocuronium and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2006to 2 Mar 2007
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants at least 20 years but under 65 years of age;
- Participants of American Society of Anesthesiologists (ASA) class 1-3;
- Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
- Participants scheduled for a surgical procedure in supine position;
- Participants who had given written informed consent.
Who cannot join
- Participants in whom difficult intubation was expected because of anatomical malformations;
- Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
- Participants known or suspected to have a (family) history of malignant hyperthermia;
- Participants known or suspected to have an allergy to medications used during general anesthesia;
- Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg^2+; based on the dose and time of administration;
- Pregnant or lactating females;
Show all 9Show fewer
- Female participants of childbearing potential not using any birth control or using only hormonal contraception as birth control;
- Participants who had already participated in trial CT 19.4.312, or in another trial with sugammadex;
- Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.
About this study
Official title: A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.
- Conditions
- Anesthesia, General
- Being tested
- Sugammadex, Rocuronium, Sevoflurane, Propofol
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
Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
RocuroniumDrug
Also called Esmeron®, Rocuronium Bromide
Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium
SevofluraneDrug
Also called Ultane®
Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.
PropofolDrug
Also called Diprivan®
Propofol IV administered for induction and maintenance of anesthesia, based on randomization.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex + Sevoflurane | Experimental | After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. Receives: Drug: Sugammadex; Drug: Rocuronium; Drug: Sevoflurane |
| Sugammadex + Propofol | Experimental | After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. Receives: Drug: Sugammadex; Drug: Rocuronium; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.
Measured: Up to 3 minutes after sugammadex administration
Secondary outcomes (2)
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB.
Measured: Up to 3 minutes after sugammadex administration
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.8 indicates a faster recovery from NMB.
Measured: Up to 3 minutes after sugammadex administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study start7 Dec 2006
- Primary completion2 Mar 2007
- Study completion2 Mar 2007
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559468
- Sponsor's protocol ID
- P05949
- Other IDs
- 19.4.312, MK-8616-028, 2006-004072-12
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2007
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rex C, Wagner S, Spies C, Scholz J, Rietbergen H, Heeringa M, Wulf H. Reversal of neuromuscular blockade by sugammadex after continuous infusion of rocuronium in patients randomized to sevoflurane or propofol maintenance anesthesia. Anesthesiology. 2009 Jul;111(1):30-5. doi: 10.1097/ALN.0b013e3181a51cb0.
PubMed 19512873
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane
- ClinicalTrials.gov ID
- NCT00559468
- Acronym / sponsor ID
- P05949
- Conditions
- Anesthesia, General
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2006 (actual)
- Primary completion
- 2 Mar 2007 (actual)
- Study completion
- 2 Mar 2007 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Posted 8 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex + Sevoflurane | Experimental | Drug: Sugammadex, Drug: Rocuronium, Drug: SevofluraneAfter receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. |
| Sugammadex + Propofol | Experimental | Drug: Sugammadex, Drug: Rocuronium, Drug: PropofolAfter receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants at least 20 years but under 65 years of age;
- Participants of American Society of Anesthesiologists (ASA) class 1-3;
- Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
- Participants scheduled for a surgical procedure in supine position;
- Participants who had given written informed consent.
Key exclusion criteria (9 listed)
- Participants in whom difficult intubation was expected because of anatomical malformations;
- Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
- Participants known or suspected to have a (family) history of malignant hyperthermia;
- Participants known or suspected to have an allergy to medications used during general anesthesia;
- Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg^2+; based on the dose and time of administration;
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-8616Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium | Drug | Sugammadex + Propofol, Sugammadex + Sevoflurane |
| RocuroniumAlso: Esmeron®, Rocuronium BromideSingle bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium | Drug | Sugammadex + Propofol, Sugammadex + Sevoflurane |
| SevofluraneAlso: Ultane®Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization. | Drug | Sugammadex + Sevoflurane |
| PropofolAlso: Diprivan®Propofol IV administered for induction and maintenance of anesthesia, based on randomization. | Drug | Sugammadex + Propofol |
Primary outcome
Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
Time frame: Up to 3 minutes after sugammadex administration
Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.
2 secondary outcomes
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Time frame: Up to 3 minutes after sugammadex administration
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8
Time frame: Up to 3 minutes after sugammadex administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19512873Rex C, Wagner S, Spies C, Scholz J, Rietbergen H, Heeringa M, Wulf H. Reversal of neuromuscular blockade by sugammadex after continuous infusion of rocuronium in patients randomized to sevoflurane or propofol maintenance anesthesia. Anesthesiology. 2009 Jul;111(1):30-5. doi: 10.1097/ALN.0b013e3181a51cb0.
- 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, Rocuronium and Sevoflurane 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 25 Nov 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 8 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 Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 (time frame: Up to 3 minutes after sugammadex administration). 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 NCT00559468, 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 25 Nov 2019.