Anesthesia, GeneralPhase 2NCT00535743
Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)
A Phase 2 study testing Sugammadex and Esmeron® in people with Anesthesia, General, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American… 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 Esmeron®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2004to 20 Jul 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of ASA class 1 - 3, above or equal to the age of 18 years;
- Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
- Participants scheduled for surgical procedures in supine position;
- Participants who had given written informed consent.
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 blocking and/or significant renal 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 known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;
- Participants who had already participated in this trial;
Show all 10Show fewer
- Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;
- Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
- Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence;
- Female participants who were breast-feeding.
About this study
Official title: A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 and 1.2 mg/kg Rocuronium Bromide
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Read the detailed description
In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.
- Conditions
- Anesthesia, General
- Being tested
- Sugammadex, Placebo, Esmeron®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Org 25969, MK-8616, BRIDION®
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
PlaceboDrug
Also called NaCl 0.9%
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
Esmeron®Drug
Also called Zemuron®, Rocuronium bromide
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
| Study group | Role | What they receive |
|---|---|---|
| Arm A. Placebo; 3 min after 1 mg/kg Esmeron® | Placebo comparator | Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron® |
| Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm G. Placebo; 15 min after 1 mg/kg Esmeron® | Placebo comparator | Placebo (single intravenous (IV) bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron® |
| Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron® | Placebo comparator | Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron® |
| Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron® | Placebo comparator | Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Placebo; Drug: Esmeron® |
| Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
| Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. Receives: Drug: Sugammadex; Drug: Esmeron® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment 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 240 minutes following administration of study treatment
Secondary outcomes (3)
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8
Mean time from start of study treatment 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 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 200 minutes following administration of study treatment
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7
Mean time from start of study treatment 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 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 180 minutes following administration of study treatment
Number of Participants Experiencing an Adverse Event
The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Measured: Up to 7 days following administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study start4 Mar 2004
- Primary completion20 Jul 2004
- Study completion20 Jul 2004
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
- 174 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
- NCT00535743
- Sponsor's protocol ID
- P05944
- Other IDs
- 19.4.206, MK-8616-024
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2007
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
PubMed 18648227
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 and 1.2 mg/kg Rocuronium Bromide
- ClinicalTrials.gov ID
- NCT00535743
- Acronym / sponsor ID
- P05944
- Conditions
- Anesthesia, General
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2004 (actual)
- Primary completion
- 20 Jul 2004 (actual)
- Study completion
- 20 Jul 2004 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 11 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 this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Detailed description
In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| Arm A. Placebo; 3 min after 1 mg/kg Esmeron® | Placebo comparator | Drug: Placebo, Drug: Esmeron®Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm G. Placebo; 15 min after 1 mg/kg Esmeron® | Placebo comparator | Drug: Placebo, Drug: Esmeron®Placebo (single intravenous (IV) bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. |
| Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron® | Placebo comparator | Drug: Placebo, Drug: Esmeron®Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron® | Placebo comparator | Drug: Placebo, Drug: Esmeron®Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
| Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® | Experimental | Drug: Sugammadex, Drug: Esmeron®Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants of ASA class 1 - 3, above or equal to the age of 18 years;
- Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
- Participants scheduled for surgical procedures in supine position;
- Participants who had given written informed consent.
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 blocking and/or significant renal 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 known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: Org 25969, MK-8616, BRIDION®Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight. | Drug | Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® |
| PlaceboAlso: NaCl 0.9%0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, | Drug | Arm A. Placebo; 3 min after 1 mg/kg Esmeron®, Arm G. Placebo; 15 min after 1 mg/kg Esmeron®, Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®, Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron® |
| Esmeron®Also: Zemuron®, Rocuronium bromideEsmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight. | Drug | Arm A. Placebo; 3 min after 1 mg/kg Esmeron®, Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®, Arm G. Placebo; 15 min after 1 mg/kg Esmeron®, Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®, Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®, Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®, Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron®, Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®, Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron® |
Primary outcome
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Time frame: Up to 240 minutes following administration of study treatment
Mean time from start of study treatment 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).
3 secondary outcomes
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8
Time frame: Up to 200 minutes following administration of study treatment
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7
Time frame: Up to 180 minutes following administration of study treatment
Number of Participants Experiencing an Adverse Event
Time frame: Up to 7 days following administration of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 18648227Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Anesthesia, General
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
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 and Esmeron® 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 4 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 11 Feb 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 11 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 of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 (time frame: Up to 240 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 NCT00535743, 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 11 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.