Anesthesia, GeneralPhase 2NCT00552617

A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

A Phase 2 study testing Sugammadex, Rocuronium and Vecuronium 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.

Official record

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Trial summary

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1)… 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 Vecuronium
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: No sites listed yet
Study dates: 20 Sep 2005to 31 Aug 2006
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 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is of American Society of Anesthesiologists (ASA) class 1 - 3;
Is at least 20 years but under 65 years of age;
Caucasian participants;
Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;
Has given written informed consent.

Who cannot join

Participants in whom a difficult intubation because of anatomical malformations was expected;
Is known or suspected to have neuromuscular disorders impairing neuromuscular blocking (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Is known or suspected to have a (family) history of malignant hyperthermia;
Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Females who were pregnant;

Show all 10Show fewer

Females of childbearing potential not using birth control or using only oral contraception as birth control;
Was breast-feeding;
Has already participated in P05971, or in another trial with sugammadex;
Has participated in another clinical trial, not preapproved by the Sponsor, within 6 months of entering into P05971.

About this study

Official title: A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects

Read the detailed description

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial P05971 was conducted in Europe and set up to establish the dose response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were to be evaluated.

Conditions: Anesthesia, General
Being tested: Sugammadex, Placebo, Rocuronium, Vecuronium

What participants receive

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

SugammadexDrug
Also called Org 25969
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
PlaceboDrug
After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of Placebo IV was administered
RocuroniumDrug
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary.
VecuroniumDrug
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

Study groups in NCT00552617
Study group	Role	What they receive
Rocuronium + Placebo	Placebo comparator	After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. Receives: Drug: Placebo; Drug: Rocuronium
Rocuronium + 0.5 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Rocuronium
Rocuronium + 1.0 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Rocuronium
Rocuronium + 2.0 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Rocuronium
Rocuronium + 4.0 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Rocuronium
Vecuronium + Placebo	Placebo comparator	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. Receives: Drug: Placebo; Drug: Vecuronium
Vecuronium + 0.5 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Vecuronium
Vecuronium + 1.0 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Vecuronium
Vecuronium + 2.0 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Vecuronium
Vecuronium + 4.0 mg/kg Sugammadex	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex; Drug: Vecuronium

What is being measured

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

Time From Start of Administration of Sugammadex or Placebo to Recovery of the 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 of up to 1.0) indicates the extent of recovery from neuromuscular blockade (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: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)

Secondary outcomes (2)

Time From Start of Administration of Sugammadex or Placebo 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 of up to 1.0) 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: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)
Time From Start of Administration of Sugammadex or Placebo 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 of up to 1.0) 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: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (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.

20 Sep 200531 Aug 2006

First posted2 Nov 2007 (estimated)
Study start20 Sep 2005
Primary completion31 Aug 2006
Study completion31 Aug 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00552617
Sponsor's protocol ID: P05971
Other IDs: 19.4.208B, MK-8616-035, 2005-001133-15, 2005
Status last verified: Nov 2019
First submitted: 31 Oct 2007
Last updated: 25 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Puhringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.
PubMed 20876699

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 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects
ClinicalTrials.gov ID: NCT00552617
Acronym / sponsor ID: P05971
Conditions: Anesthesia, General
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Sep 2005 (actual)
Primary completion: 31 Aug 2006 (actual)
Study completion: 31 Aug 2006 (actual)
First posted: 2 Nov 2007 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Rocuronium + Placebo	Placebo comparator	Drug: Placebo, Drug: RocuroniumAfter induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Rocuronium + 0.5 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: RocuroniumAfter induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Rocuronium + 1.0 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: RocuroniumAfter induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
Rocuronium + 2.0 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: RocuroniumAfter induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
Rocuronium + 4.0 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: RocuroniumAfter induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
Vecuronium + Placebo	Placebo comparator	Drug: Placebo, Drug: VecuroniumAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Vecuronium + 0.5 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: VecuroniumAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Vecuronium + 1.0 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: VecuroniumAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
Vecuronium + 2.0 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: VecuroniumAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
Vecuronium + 4.0 mg/kg Sugammadex	Experimental	Drug: Sugammadex, Drug: VecuroniumAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Is of American Society of Anesthesiologists (ASA) class 1 - 3;
Is at least 20 years but under 65 years of age;
Caucasian participants;
Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;
Has given written informed consent.

Key exclusion criteria (10 listed)

Participants in whom a difficult intubation because of anatomical malformations was expected;
Is known or suspected to have neuromuscular disorders impairing neuromuscular blocking (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Is known or suspected to have a (family) history of malignant hyperthermia;
Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, 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 25969After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered	Drug	Rocuronium + 0.5 mg/kg Sugammadex, Rocuronium + 1.0 mg/kg Sugammadex, Rocuronium + 2.0 mg/kg Sugammadex, Rocuronium + 4.0 mg/kg Sugammadex, Vecuronium + 0.5 mg/kg Sugammadex, Vecuronium + 1.0 mg/kg Sugammadex, Vecuronium + 2.0 mg/kg Sugammadex, Vecuronium + 4.0 mg/kg Sugammadex
PlaceboAfter induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of Placebo IV was administered	Drug	Rocuronium + Placebo, Vecuronium + Placebo
RocuroniumAfter induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary.	Drug	Rocuronium + 0.5 mg/kg Sugammadex, Rocuronium + 1.0 mg/kg Sugammadex, Rocuronium + 2.0 mg/kg Sugammadex, Rocuronium + 4.0 mg/kg Sugammadex, Rocuronium + Placebo
VecuroniumAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.	Drug	Vecuronium + 0.5 mg/kg Sugammadex, Vecuronium + 1.0 mg/kg Sugammadex, Vecuronium + 2.0 mg/kg Sugammadex, Vecuronium + 4.0 mg/kg Sugammadex, Vecuronium + Placebo

Primary outcome

Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
Time frame: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)
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 of up to 1.0) indicates the extent of recovery from neuromuscular blockade (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

Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7
Time frame: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)
Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8
Time frame: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)

Results and safety

Results posted to the registry on 15 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
Rocuronium + Placebo	10	10
Rocuronium + 0.5 mg/kg Sugammadex	10	10
Rocuronium + 1.0 mg/kg Sugammadex	10	9
Rocuronium + 2.0 mg/kg Sugammadex	10	9
Rocuronium + 4.0 mg/kg Sugammadex	10	10
Vecuronium + Placebo	10	8
Vecuronium + 0.5 mg/kg Sugammadex	10	10
Vecuronium + 1.0 mg/kg Sugammadex	10	10
Vecuronium + 2.0 mg/kg Sugammadex	10	8
Vecuronium + 4.0 mg/kg Sugammadex	10	9

Primary outcome: Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9

Time frame: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours). Mean (Standard Deviation). Unit: Minutes

Measure	Rocuronium + Placebo n = 7	Rocuronium + 0.5 mg/kg Sugammadex n = 8	Rocuronium + 1.0 mg/kg Sugammadex n = 8	Rocuronium + 2.0 mg/kg Sugammadex n = 9	Rocuronium + 4.0 mg/kg Sugammadex n = 8	Vecuronium + Placebo n = 8	Vecuronium + 0.5 mg/kg Sugammadex n = 9	Vecuronium + 1.0 mg/kg Sugammadex n = 10	Vecuronium + 2.0 mg/kg Sugammadex n = 7	Vecuronium + 4.0 mg/kg Sugammadex n = 9
Value	96.30 (33.13)	16.30 (20.60)	4.62 (5.97)	1.43 (0.50)	1.50 (0.40)	79.02 (25.97)	35.50 (42.13)	5.07 (2.38)	3.42 (1.85)	3.03 (2.18)

Population analysed: All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.

2 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Rocuronium + Placebo	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Rocuronium + 0.5 mg/kg Sugammadex	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Rocuronium + 1.0 mg/kg Sugammadex	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Rocuronium + 2.0 mg/kg Sugammadex	1 of 10 (10%)	10 of 10 (100%)	1 of 10
Rocuronium + 4.0 mg/kg Sugammadex	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Vecuronium + Placebo	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Vecuronium + 0.5 mg/kg Sugammadex	2 of 10 (20%)	10 of 10 (100%)	0 of 10
Vecuronium + 1.0 mg/kg Sugammadex	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Vecuronium + 2.0 mg/kg Sugammadex	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Vecuronium + 4.0 mg/kg Sugammadex	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9

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 20876699Puhringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.
Click here to access a synopsis of the study results.Link provided by the sponsor.

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Airway Edema, Postoperative Complications

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, Rocuronium and Vecuronium 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 10 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. 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 15 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?

Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 (time frame: Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)). 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 NCT00552617, 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.