Neuromuscular BlockadePhase 4NCT03346070

Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)

A Phase 4 study testing Sugammadex 2 mg/kg ABW, Sugammadex 2 mg/kg IBW and Sugammadex 4 mg/kg ABW in people with Neuromuscular Blockade, run by Merck Sharp & Dohme LLC at 24 sites in 5 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Sugammadex 2 mg/kg ABW, Sugammadex 2 mg/kg IBW and Sugammadex 4 mg/kg ABW
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 24 sitesin 5 countries
Study dates: 1 Jan 2018to 29 Jan 2019
Phase: Phase 4
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

Have BMI ≥40 kg/m² (morbidly obese).
Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 3
Have a planned surgical procedure that requires neuromuscular block with either rocuronium or vecuronium.
Have a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic procedures) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case (maintained by re-dosing or continuous infusion).
Have a planned surgical procedure that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring.
If female, who is not of reproductive potential, be one of the following: 1) postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age; 2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; 3) has a congenital or acquired condition that prevents childbearing; or 4) is undergoing surgical sterilization as the planned surgical procedure associated with participation in this study (e.g., hysterectomy or tubal ligation).
If female, who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Please note the following: 1) Medically accepted methods of contraception include condoms (male or female) with a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or copper-containing IUD, surgical sterilization (e.g., hysterectomy or tubal ligation); 2) Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Human Subjects Protection Review Boards; 3 Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception; 4) If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region.
Be able to provide (or the subject's legally authorized representative in accordance with local requirements), written informed consent for the trial. The participant or legally authorized representative may also provide consent for Future Biomedical Research.

Who cannot join

Have an actual body weight <100 kg.
Have a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.
Have a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
Have neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
Are dialysis-dependent or have severe renal insufficiency (defined as estimated creatinine clearance of <30 mL/min.).
Have or are suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.

Show all 12Show fewer

Have or are suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
Have received or are planning to receive toremifene within 24 hours before or within 24 hours after study medication administration.
Have any condition that would contraindicate the administration of study medication.
Are currently pregnant, attempting to become pregnant, or lactating.
Have any clinically significant condition or situation (e.g., anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
Are currently participating in or has participated in an interventional clinical trial with an investigational compound (including any other current or ongoing trial with a Sugammadex treatment arm) or device within 30 days of signing the informed consent form of this current trial.

Trial locations and contacts

24 sites in 5 countries.

Country

City, postcode or hospital

24 sites in 5 countries

United States13 sites

Mission Hospital - St. Joseph ( Site 2015)
Asheville, North Carolina, 28801
Cleveland Clinic Foundation ( Site 2031)
Cleveland, Ohio, 44195
University Hospital- Columbia MO ( Site 2060)
Columbia, Missouri, 65212
Hermann Drive Surgical Center ( Site 2020)
Houston, Texas, 77004
Hermann Drive Surgical Center ( Site 2059)
Houston, Texas, 77004
University of Kansas Medical Center ( Site 2049)
Kansas City, Kansas, 66160
Jackson Memorial Hospital/University of Miami ( Site 2007)
Miami, Florida, 33136
Zablocki VA Medical Center ( Site 2011)
Milwaukee, Wisconsin, 53295
Vanderbilt University Medical Center ( Site 2032)
Nashville, Tennessee, 37232
Robert Wood Johnson University Hospital ( Site 2037)
New Brunswick, New Jersey, 08901
Temple University Hospital ( Site 2004)
Philadelphia, Pennsylvania, 19140
William Beaumont Hospital - Royal Oak ( Site 2033)
Royal Oak, Michigan, 48073
University California / Davis ( Site 2001)
Sacramento, California, 95817

Other trials in United States

Germany7 sites

Johanniter Krankenhaus Bonn ( Site 2353)
Bonn, 53113
Diakovere Annastift gGmbH ( Site 2355)
Hanover, 30625
Universitatsklinikum Giessen und Marburg GmbH ( Site 2356)
Marburg, 35043
Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 2350)
München, 81675
St. Franziskus-Hospital ( Site 2354)
Münster, 48145
Klinikum am Steinenberg Reutlingen ( Site 2352)
Reutlingen, 72764
Josephs-Hospitals Warendorf ( Site 2351)
Warendorf, 48231

Other trials in Germany

Denmark2 sites

Rigshospitalet ( Site 2253)
Copenhagen, 2100
Bispebjerg og Frederiksberg Hospital ( Site 2250)
Copenhagen NV, 2400

Other trials in Denmark

Austria1 site

Sozialmedizinisches Zentrum Ost - Donauspital ( Site 2150)
Vienna, 1220

Other trials in Austria

Belgium1 site

Universitaire Ziekenhuis Antwerpen - UZA ( Site 2200)
Edegem, 2650

Other trials in Belgium

About this study

Official title: A Phase 4 Randomized, Active-Comparator Controlled Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in Morbidly Obese Subjects

The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.

Conditions: Neuromuscular Blockade
Being tested: Sugammadex 2 mg/kg ABW, Sugammadex 2 mg/kg IBW, Sugammadex 4 mg/kg ABW, Sugammadex 4 mg/kg IBW, Neostigmine + Glycopyrrolate

What participants receive

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

Sugammadex 2 mg/kg ABWDrug
Also called MK-8616
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB.
Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations.
Sugammadex 2 mg/kg IBWDrug
Also called MK-8616
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB.
Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.
Sugammadex 4 mg/kg ABWDrug
Also called MK-8616
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB.
Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).
Sugammadex 4 mg/kg IBWDrug
Also called MK-8616
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB.
Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).
Neostigmine + GlycopyrrolateDrug
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB.
Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.
Rocuronium or VecuroniumDrug
To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.

Study groups in NCT03346070
Study group	Role	What they receive
Sugammadex 2 mg/kg ABW	Experimental	Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. Receives: Drug: Sugammadex 2 mg/kg ABW; Drug: Rocuronium or Vecuronium
Sugammadex 2 mg/kg IBW	Experimental	Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. Receives: Drug: Sugammadex 2 mg/kg IBW; Drug: Rocuronium or Vecuronium
Sugammadex 4 mg/kg ABW	Experimental	Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. Receives: Drug: Sugammadex 4 mg/kg ABW; Drug: Rocuronium or Vecuronium
Sugammadex 4 mg/kg IBW	Experimental	Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. Receives: Drug: Sugammadex 4 mg/kg IBW; Drug: Rocuronium or Vecuronium
Neostigmine/Glycopyrrolate	Active comparator	Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. Receives: Drug: Neostigmine + Glycopyrrolate; Drug: Rocuronium or Vecuronium

What is being measured

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

Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis
The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 76 minutes
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 35 minutes
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 35 minutes
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 35 minutes
Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention
The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 7 days
Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention
The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 7 days
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention
The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 7 days

Secondary outcomes (4)

Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9
Following administration of study intervention, the percentage of participants experiencing prolonged (>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 76 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis
The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 76 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis
The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 69 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis
The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Measured: Up to 61 minutes

Timeline

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

1 Jan 201829 Jan 2019

First posted17 Nov 2017
Study start1 Jan 2018
Primary completion29 Jan 2019
Study completion29 Jan 2019

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 (2)Papers the sponsor has linked to this study.
Other trials for Neuromuscular BlockadeStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03346070
Sponsor's protocol ID: 8616-146
Other IDs: 2017-000188-33, MK-8616-146, 2017
Status last verified: Jan 2021
First submitted: 15 Nov 2017
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Mostoller K, Wrishko R, Maganti L, Herring WJ, van Zutphen-van Geffen M. Pharmacokinetics of Sugammadex Dosed by Actual and Ideal Body Weight in Patients With Morbid Obesity Undergoing Surgery. Clin Transl Sci. 2021 Mar;14(2):737-744. doi: 10.1111/cts.12941. Epub 2020 Dec 16.
PubMed 33278332
Horrow JC, Li W, Blobner M, Lombard J, Speek M, DeAngelis M, Herring WJ. Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial. BMC Anesthesiol. 2021 Feb 27;21(1):62. doi: 10.1186/s12871-021-01278-w.
PubMed 33639839

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?
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Could I receive a placebo instead of the treatment?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4 Randomized, Active-Comparator Controlled Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in Morbidly Obese Subjects
ClinicalTrials.gov ID: NCT03346070
Acronym / sponsor ID: 8616-146
Conditions: Neuromuscular Blockade
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Jan 2018 (actual)
Primary completion: 29 Jan 2019 (actual)
Study completion: 29 Jan 2019 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 23 Dec 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Sugammadex 2 mg/kg ABW	Experimental	Drug: Sugammadex 2 mg/kg ABW, Drug: Rocuronium or VecuroniumFollowing administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
Sugammadex 2 mg/kg IBW	Experimental	Drug: Sugammadex 2 mg/kg IBW, Drug: Rocuronium or VecuroniumFollowing administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
Sugammadex 4 mg/kg ABW	Experimental	Drug: Sugammadex 4 mg/kg ABW, Drug: Rocuronium or VecuroniumFollowing administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
Sugammadex 4 mg/kg IBW	Experimental	Drug: Sugammadex 4 mg/kg IBW, Drug: Rocuronium or VecuroniumFollowing administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
Neostigmine/Glycopyrrolate	Active comparator	Drug: Neostigmine + Glycopyrrolate, Drug: Rocuronium or VecuroniumFollowing administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.

Who may qualify

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

Key inclusion criteria (8 listed)

Have BMI ≥40 kg/m² (morbidly obese).
Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 3
Have a planned surgical procedure that requires neuromuscular block with either rocuronium or vecuronium.
Have a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic procedures) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case (maintained by re-dosing or continuous infusion).
Have a planned surgical procedure that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring.

Key exclusion criteria (12 listed)

Have an actual body weight <100 kg.
Have a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.
Have a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
Have neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
Are dialysis-dependent or have severe renal insufficiency (defined as estimated creatinine clearance of <30 mL/min.).

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
Sugammadex 2 mg/kg ABWAlso: MK-8616Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB. Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations.	Drug	Sugammadex 2 mg/kg ABW
Sugammadex 2 mg/kg IBWAlso: MK-8616Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB. Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.	Drug	Sugammadex 2 mg/kg IBW
Sugammadex 4 mg/kg ABWAlso: MK-8616Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB. Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).	Drug	Sugammadex 4 mg/kg ABW
Sugammadex 4 mg/kg IBWAlso: MK-8616Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB. Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).	Drug	Sugammadex 4 mg/kg IBW
Neostigmine + GlycopyrrolateFollowing administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB. Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.	Drug	Neostigmine/Glycopyrrolate
Rocuronium or VecuroniumTo achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.	Drug	Neostigmine/Glycopyrrolate, Sugammadex 2 mg/kg ABW, Sugammadex 2 mg/kg IBW, Sugammadex 4 mg/kg ABW, Sugammadex 4 mg/kg IBW

Primary outcome

Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis
Time frame: Up to 76 minutes
The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
Time frame: Up to 35 minutes
The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
Time frame: Up to 35 minutes
The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
Time frame: Up to 35 minutes
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention
Time frame: Up to 7 days
The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention
Time frame: Up to 7 days
The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention
Time frame: Up to 7 days
The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).

4 secondary outcomes

Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9
Time frame: Up to 76 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis
Time frame: Up to 76 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis
Time frame: Up to 69 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis
Time frame: Up to 61 minutes

Results and safety

Results posted to the registry on 23 Dec 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 2 mg/kg Actual Body Weight (ABW)	41	38
Sugammadex 4 mg/kg ABW	41	37
Sugammadex 2 mg/kg Ideal Body Weight (IBW)	41	37
Sugammadex 4 mg/kg IBW	42	36
Neostigmine/Glycopyrrolate	42	37

Primary outcome: Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis

Time frame: Up to 76 minutes. Median (95% Confidence Interval). Unit: Minutes

Measure	Sugammadex 2 mg/kg ABW n = 38	Sugammadex 4 mg/kg ABW n = 37	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n = 75	Sugammadex 2 mg/kg IBW n = 37	Sugammadex 4 mg/kg IBW n = 36	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n = 73	Neostigmine/Glycopyrrolate n = 38
Value	1.7 (1.5 to 2.1)	1.8 (1.5 to 2.1)	1.8 (1.6 to 2.1)	3.4 (2.2 to 4.4)	3.3 (2.4 to 4.2)	3.3 (2.6 to 4.1)	34.5 (27.0 to 67.4)

Sugammadex 2 mg/kg ABW vs Sugammadex 2 mg/kg IBW: Hazard Ratio (HR): 1.92 (95% CI 1.18 to 3.10), p = 0.0075, Log Rank
Sugammadex 2 mg/kg ABW vs Neostigmine/Glycopyrrolate: Hazard Ratio (HR): 25.90 (95% CI 9.72 to 69.03), p <0.0001, Log Rank
Sugammadex 2 mg/kg IBW vs Neostigmine/Glycopyrrolate: Hazard Ratio (HR): 61.40 (95% CI 14.13 to 266.77), p <0.0001, Log Rank

Population analysed: All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

Primary outcome: Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events

Time frame: Up to 35 minutes. Number. Unit: Percentage of participants

Measure	Sugammadex 2 mg/kg ABW n = 38	Sugammadex 4 mg/kg ABW n = 38	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n = 76	Sugammadex 2 mg/kg IBW n = 38	Sugammadex 4 mg/kg IBW n = 36	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n = 74	Neostigmine/Glycopyrrolate n = 38
Value	5.3	5.3	5.3	2.6	5.6	4.1	2.6

Sugammadex 2 mg/kg ABW vs Sugammadex 2 mg/kg IBW: Difference in percentage: 2.3 (95% CI -9.6 to 15.0), p = 0.602, Miettinen & Nurminen method
Sugammadex 4 mg/kg ABW vs Sugammadex 4 mg/kg IBW: Difference in percentage: 0.2 (95% CI -13.4 to 13.5), p = 0.969, Miettinen & Nurminen method
Sugammadex 2 mg/kg ABW vs Neostigmine/Glycopyrrolate: Difference in percentage: 2.6 (95% CI -8.7 to 15.0), p = 0.567, Miettinen & Nurminen method

Population analysed: All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.

Primary outcome: Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events

Time frame: Up to 35 minutes. Number. Unit: Percentage of participants

Measure	Sugammadex 2 mg/kg ABW n = 38	Sugammadex 4 mg/kg ABW n = 38	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n = 76	Sugammadex 2 mg/kg IBW n = 38	Sugammadex 4 mg/kg IBW n = 36	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n = 74	Neostigmine/Glycopyrrolate n = 38
Value	10.5	13.2	11.8	7.9	2.8	5.4	7.9

Sugammadex 2 mg/kg ABW vs Sugammadex 2 mg/kg IBW: Difference in percentage: 2.2 (95% CI -12.3 to 17.4), p = 0.738, Miettinen & Nurminen method
Sugammadex 4 mg/kg ABW vs Sugammadex 4 mg/kg IBW: Difference in percentage: 11.1 (95% CI -1.7 to 26.3), p = 0.077, Miettinen & Nurminen method
Sugammadex 2 mg/kg ABW vs Neostigmine/Glycopyrrolate: Difference in percentage: 2.4 (95% CI -12.0 to 16.4), p = 0.717, Miettinen & Nurminen method

Primary outcome: Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events

Time frame: Up to 35 minutes. Number. Unit: Percentage of participants

Measure	Sugammadex 2 mg/kg ABW n = 38	Sugammadex 4 mg/kg ABW n = 38	Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) n = 76	Sugammadex 2 mg/kg IBW n = 38	Sugammadex 4 mg/kg IBW n = 36	Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) n = 74	Neostigmine/Glycopyrrolate n = 38
Value	0.0	0.0	0.0	2.6	0.0	1.4	2.6

Sugammadex 2 mg/kg ABW vs Sugammadex 2 mg/kg IBW: Difference in percentage: -2.7 (95% CI -13.9 to 6.7), p = 0.299, Miettinen & Nurminen method
Sugammadex 4 mg/kg ABW vs Sugammadex 4 mg/kg IBW: Difference in percentage: 0.0 (95% CI -9.9 to 9.4), p >0.999, Miettinen & Nurminen method
Sugammadex 2 mg/kg ABW vs Neostigmine/Glycopyrrolate: Difference in percentage: -2.6 (95% CI -13.7 to 7.0), p = 0.326, Miettinen & Nurminen method

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex 2 mg/kg ABW	1 of 38 (2.6%)	36 of 38 (94.7%)	0 of 38
Sugammadex 4 mg/kg ABW	0 of 38 (0%)	32 of 38 (84.2%)	0 of 38
Sugammadex 2 mg/kg IBW	3 of 38 (7.9%)	36 of 38 (94.7%)	0 of 38
Sugammadex 4 mg/kg IBW	4 of 36 (11.1%)	32 of 36 (88.9%)	0 of 36
Neostigmine + Glycopyrrolate	3 of 38 (7.9%)	32 of 38 (84.2%)	1 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33278332Mostoller K, Wrishko R, Maganti L, Herring WJ, van Zutphen-van Geffen M. Pharmacokinetics of Sugammadex Dosed by Actual and Ideal Body Weight in Patients With Morbid Obesity Undergoing Surgery. Clin Transl Sci. 2021 Mar;14(2):737-744. doi: 10.1111/cts.12941. Epub 2020 Dec 16.
Derived from this study: PubMed 33639839Horrow JC, Li W, Blobner M, Lombard J, Speek M, DeAngelis M, Herring WJ. Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial. BMC Anesthesiol. 2021 Feb 27;21(1):62. doi: 10.1186/s12871-021-01278-w.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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

24 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sugammadex 2 mg/kg ABW, Sugammadex 2 mg/kg IBW and Sugammadex 4 mg/kg ABW in people with Neuromuscular Blockade, run by Merck Sharp & Dohme LLC at 24 sites in 5 countries.

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 8 inclusion and 12 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Germany, Denmark, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 23 Dec 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 to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis (time frame: Up to 76 minutes). The study lists 7 primary outcomes in all. 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 NCT03346070, which also lists 2 linked publications.

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 28 Jan 2021.