Anesthesia, GeneralPhase 2NCT00591786

A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)

A Phase 2 study testing Sugammadex 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 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 1-2 PTC during sevoflurane anesthesia for Japanese participants. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 5 Dec 2005to 19 Oct 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

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Japanese participants;
Participants scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5-3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Who cannot join

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

Show all 10Show fewer

Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in study CT 19.4.209A, or in another trial with sugammadex;
Participants who had participated in another clinical trial within 6 months of entering into study CT 19.4.209A.

About this study

Official title: A Multi-center, Randomized, Open-label, Prospective Bridging, Parallel Dose Finding Trial Comparing Efficacy and Safety of 5 Doses of Org 25969 Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part A: Japanese Subjects.

Conditions: Anesthesia, General
Being tested: Sugammadex

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®
After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.

Study groups in NCT00591786
Study group	Role	What they receive
Sugammadex 0.5 mg/kg (Rocuronium)	Experimental	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 the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 1.0 mg/kg (Rocuronium)	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 the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 2.0 mg/kg (Rocuronium)	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 the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 4.0 mg/kg (Rocuronium)	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 the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 8.0 mg/kg (Rocuronium)	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 the T2 response to TOF stimulation, a single dose of 0.8 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 0.5 mg/kg (Vecuronium)	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 1.0 mg/kg (Vecuronium)	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 2.0 mg/kg (Vecuronium)	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 4.0 mg/kg (Vecuronium)	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex
Sugammadex 8.0 mg/kg (Vecuronium)	Experimental	After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 mg/kg sugammadex was administered IV. Receives: Drug: Sugammadex

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 the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation
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: Up to 269:45 (min:sec)

Secondary outcomes (2)

Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF Stimulation
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: Up to 152:30 (min:sec)
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF Stimulation
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: Up to 194:45 (min:sec)

Timeline

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

5 Dec 200519 Oct 2006

First posted11 Jan 2008 (estimated)
Study start5 Dec 2005
Primary completion31 Aug 2006
Study completion19 Oct 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: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00591786
Sponsor's protocol ID: P05957
Other IDs: 2005-001133-15, MK-8616-031, 19.4.209A, 2005
Status last verified: Feb 2019
First submitted: 27 Dec 2007
Last updated: 15 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Takeda J, Iwasaki H, Otagiri T, Katoh T, Shingu K, Obara H, Nakatsuka H, Tomiyama Y, Kasaba T. [Efficacy and safety of sugammadex (Org 25969) in reversing deep neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1083-8. Japanese.
PubMed 25693333

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 15 Mar 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 and Safety of 5 Doses of Org 25969 Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part A: Japanese Subjects.
ClinicalTrials.gov ID: NCT00591786
Acronym / sponsor ID: P05957
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: 5 Dec 2005 (actual)
Primary completion: 31 Aug 2006 (actual)
Study completion: 19 Oct 2006 (actual)
First posted: 11 Jan 2008 (estimated)
Results: Posted 18 Feb 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Sugammadex 0.5 mg/kg (Rocuronium)	Experimental	Drug: SugammadexAfter 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 the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV.
Sugammadex 1.0 mg/kg (Rocuronium)	Experimental	Drug: SugammadexAfter 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 the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV.
Sugammadex 2.0 mg/kg (Rocuronium)	Experimental	Drug: SugammadexAfter 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 the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV.
Sugammadex 4.0 mg/kg (Rocuronium)	Experimental	Drug: SugammadexAfter 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 the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV.
Sugammadex 8.0 mg/kg (Rocuronium)	Experimental	Drug: SugammadexAfter 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 the T2 response to TOF stimulation, a single dose of 0.8 mg/kg sugammadex was administered IV.
Sugammadex 0.5 mg/kg (Vecuronium)	Experimental	Drug: SugammadexAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV.
Sugammadex 1.0 mg/kg (Vecuronium)	Experimental	Drug: SugammadexAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV.
Sugammadex 2.0 mg/kg (Vecuronium)	Experimental	Drug: SugammadexAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV.
Sugammadex 4.0 mg/kg (Vecuronium)	Experimental	Drug: SugammadexAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV.
Sugammadex 8.0 mg/kg (Vecuronium)	Experimental	Drug: SugammadexAfter induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 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)

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Japanese participants;
Participants scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5-3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Key exclusion criteria (10 listed)

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication 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 25969, MK-8616, Bridion®After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.	Drug	Sugammadex 0.5 mg/kg (Rocuronium), Sugammadex 0.5 mg/kg (Vecuronium), Sugammadex 1.0 mg/kg (Rocuronium), Sugammadex 1.0 mg/kg (Vecuronium), Sugammadex 2.0 mg/kg (Rocuronium), Sugammadex 2.0 mg/kg (Vecuronium), Sugammadex 4.0 mg/kg (Rocuronium), Sugammadex 4.0 mg/kg (Vecuronium), Sugammadex 8.0 mg/kg (Rocuronium), Sugammadex 8.0 mg/kg (Vecuronium)

Primary outcome

Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation
Time frame: Up to 269:45 (min:sec)
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 Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF Stimulation
Time frame: Up to 152:30 (min:sec)
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF Stimulation
Time frame: Up to 194:45 (min:sec)

Results and safety

Results posted to the registry on 18 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
Sugammadex 0.5 mg/kg (Rocuronium)	9	9
Sugammadex 1.0 mg/kg (Rocuronium)	9	9
Sugammadex 2.0 mg/kg (Rocuronium)	11	10
Sugammadex 4.0 mg/kg (Rocuronium)	11	11
Sugammadex 8.0 mg/kg (Rocuronium)	10	10
Sugammadex 0.5 mg/kg (Vecuronium)	10	10
Sugammadex 1.0 mg/kg (Vecuronium)	10	10
Sugammadex 2.0 mg/kg (Vecuronium)	10	10
Sugammadex 4.0 mg/kg (Vecuronium)	10	10
Sugammadex 8.0 mg/kg (Vecuronium)	10	10

Primary outcome: Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation

Time frame: Up to 269:45 (min:sec). Mean (Standard Deviation). Unit: Minutes

Measure	Sugammadex 0.5 mg/kg (Rocuronium) n = 6	Sugammadex 1.0 mg/kg (Rocuronium) n = 7	Sugammadex 2.0 mg/kg (Rocuronium) n = 10	Sugammadex 4.0 mg/kg (Rocuronium) n = 11	Sugammadex 8.0 mg/kg (Rocuronium) n = 10	Sugammadex 0.5 mg/kg (Vecuronium) n = 5	Sugammadex 1.0 mg/kg (Vecuronium) n = 7	Sugammadex 2.0 mg/kg (Vecuronium) n = 10	Sugammadex 4.0 mg/kg (Vecuronium) n = 10	Sugammadex 8.0 mg/kg (Vecuronium) n = 10
Value	66.90 (34.63)	4.73 (1.73)	3.43 (2.52)	1.58 (0.88)	1.32 (0.57)	79.48 (46.23)	39.82 (45.77)	16.02 (42.20)	3.05 (2.38)	2.93 (3.77)

Population analysed: The analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.

2 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex 0.5 mg/kg (Rocuronium)	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Sugammadex 1.0 mg/kg (Rocuronium)	1 of 9 (11.1%)	9 of 9 (100%)	0 of 9
Sugammadex 2.0 mg/kg (Rocuronium)	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Sugammadex 4.0 mg/kg (Rocuronium)	0 of 11 (0%)	11 of 11 (100%)	0 of 11
Sugammadex 8.0 mg/kg (Rocuronium)	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Sugammadex 0.5 mg/kg (Vecuronium)	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Sugammadex 1.0 mg/kg (Vecuronium)	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Sugammadex 2.0 mg/kg (Vecuronium)	1 of 10 (10%)	10 of 10 (100%)	0 of 10
Sugammadex 4.0 mg/kg (Vecuronium)	1 of 10 (10%)	9 of 10 (90%)	0 of 10
Sugammadex 8.0 mg/kg (Vecuronium)	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25693333Takeda J, Iwasaki H, Otagiri T, Katoh T, Shingu K, Obara H, Nakatsuka H, Tomiyama Y, Kasaba T. [Efficacy and safety of sugammadex (Org 25969) in reversing deep neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1083-8. Japanese.
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 2 study testing Sugammadex 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 15 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 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 18 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 Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation (time frame: Up to 269:45 (min:sec)). 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 NCT00591786, 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 15 Mar 2019.