Reversal of Neuromuscular BlockadePhase 4NCT03346057
Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
A Phase 4 study testing Sugammadex 2 mg/kg, Sugammadex 4 mg/kg and Sugammadex 16 mg/kg in people with Reversal of Neuromuscular Blockade, run by Merck Sharp & Dohme LLC at 30 sites in 4 countries.
Trial summary
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reversal of Neuromuscular Blockade
- What is being tested?
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg and Sugammadex 16 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 20 Dec 2017to 4 Sep 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
- Has a body mass index (BMI) < 40 kg/m2.
- Is categorized as ASA Physical Status Class 3 or 4, as determined by the Investigator.
- Has a planned surgical procedure that requires NMB with either rocuronium or vecuronium.
- Has a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case.
- If female who is not of reproductive potential, is one of the following: (1) postmenopausal; (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 (e.g., hysterectomy or tubal ligation) as the planned surgical procedure associated with participation in this study.
- 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. 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 Ethics Review Committees/Institutional Review Boards.
- Is able to provide (or the participant'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
- Has a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.
- Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
- Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
- Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min.
- Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
- Has or is 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.
Show all 10Show fewer
- Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.
- Has any condition that would contraindicate the administration of study medication.
- Is pregnant, is attempting to become pregnant, or is lactating.
- Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States20 sites
Mission Hospital - Memorial ( Site 1016)
Asheville, North Carolina, 28801
University of Alabama - Birmingham ( Site 1046)
Birmingham, Alabama, 35233
Brigham & Women's Hospital ( Site 1039)
Boston, Massachusetts, 02115
Cleveland Clin Foundation ( Site 1032)
Cleveland, Ohio, 44195
University Hospital- Columbia MO ( Site 1060)
Columbia, Missouri, 65212
University of Missouri Health Care ( Site 1022)
Columbia, Missouri, 65212
Hermann Drive Surgical Center ( Site 1021)
Houston, Texas, 77004
University of Kansas Medical Center ( Site 1050)
Kansas City, Kansas, 66160
Loma Linda University Medical Center ( Site 1029)
Loma Linda, California, 92354
Jackson Memorial Hospital ( Site 1007)
Miami, Florida, 33136
Zablocki VA Medical Center ( Site 1011)
Milwaukee, Wisconsin, 53295
Vanderbilt University Medical Center ( Site 1033)
Nashville, Tennessee, 37232
Jersey Shore University Medical Center ( Site 1058)
Neptune City, New Jersey, 07753
Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017)
New Brunswick, New Jersey, 08901
Tulane University ( Site 1057)
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation ( Site 1005)
New Orleans, Louisiana, 70121
Temple University Hospital ( Site 1004)
Philadelphia, Pennsylvania, 19140-5103
Beaumont Hospital, Royal Oak ( Site 1034)
Royal Oak, Michigan, 48073
University of California Davis Medical Center ( Site 1001)
Sacramento, California, 95817
University Banner Medical Center ( Site 1019)
Tucson, Arizona, 85719
Denmark4 sites
Aarhus Universitets hospital ( Site 1252)
Aarhus, 8200
Rigshospitalet ( Site 1253)
Copenhagen, 2100
Bispebjerg og Frederiksberg Hospital ( Site 1250)
Copenhagen NV, 2400
Regionshospitalet Viborg ( Site 1254)
Viborg, 8800
Austria3 sites
A.O. Krankenhaus Dornbirn ( Site 1151)
Dornbirn, Voralberg, 6850
Landeskrankenhaus Feldkirch ( Site 1152)
Feldkirch, 6800
Sozialmedizinisches Zentrum Ost - Donauspital ( Site 1150)
Vienna, 1220
Germany3 sites
Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 1350)
München, 81675
Klinikum am Steinenberg Reutlingen ( Site 1352)
Reutlingen, 72764
Josephs-Hospitals Warendorf ( Site 1351)
Warendorf, 48231
About this study
Official title: A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (ASA) Class 3 or 4 Subjects
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.
- Conditions
- Reversal of Neuromuscular Blockade
- Being tested
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg, Neostigmine + Glycopyrrolate, Rocuronium
- Keywords
- arrhythmia, bradycardia, neuromuscular blocking agents, surgery, tachycardia
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 2 mg/kgDrug
Also called MK-8616, Bridion
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
Sugammadex 4 mg/kgDrug
Also called MK-8616, Bridion
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 4 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
Sugammadex 16 mg/kgDrug
Also called MK-8616, Bridion
Following administration of NMBA (Rocuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 16 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
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) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
RocuroniumDrug
To achieve NMB, participants received steroidal NMBA Rocuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
VecuroniumDrug
To achieve NMB, participants received steroidal NMBA Vecuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex 2 mg/kg | Experimental | Sugammadex 2 mg/kg administered as a single intravenous (IV) dose Receives: Drug: Sugammadex 2 mg/kg; Drug: Rocuronium; Drug: Vecuronium |
| Sugammadex 4 mg/kg | Experimental | Sugammadex 4 mg/kg administered as a single IV dose Receives: Drug: Sugammadex 4 mg/kg; Drug: Rocuronium; Drug: Vecuronium |
| Sugammadex 16 mg/kg | Experimental | Sugammadex 16 mg/kg administered as a single IV dose Receives: Drug: Sugammadex 16 mg/kg; Drug: Rocuronium |
| Neostigmine + Glycopyrrolate | Active comparator | Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose Receives: Drug: Neostigmine + Glycopyrrolate; Drug: Rocuronium; Drug: Vecuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were 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 have been considered an adverse event (AE), as determined by investigator judgment.
Measured: Up to approximately 35 minutes post-administration
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
The percentage of participants experiencing treatment-emergent sinus tachycardia events was 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 have been considered an AE, as determined by investigator judgment.
Measured: Up to approximately 35 minutes post-administration
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.
Measured: Up to approximately 35 minutes post-administration
Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention
As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Measured: Up to 7 days
Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention
As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.
Measured: Up to 7 days
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention
As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were 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. A participant could have experienced more than one type of ECI.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start20 Dec 2017
- Primary completion4 Sep 2019
- Study completion4 Sep 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 (1)Papers the sponsor has linked to this study.
- Other trials for Reversal of 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
- 344 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
- NCT03346057
- Sponsor's protocol ID
- 8616-145
- Other IDs
- 2017-000187-15, MK-8616-145, 2017
- Status last verified
- Oct 2020
- First submitted
- 15 Nov 2017
- Last updated
- 8 Oct 2020
- 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
Herring WJ, Mukai Y, Wang A, Lutkiewicz J, Lombard JF, Lin L, Watkins M, Broussard DM, Blobner M. A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants. BMC Anesthesiol. 2021 Oct 28;21(1):259. doi: 10.1186/s12871-021-01477-5.
PubMed 34711192
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (ASA) Class 3 or 4 Subjects
- ClinicalTrials.gov ID
- NCT03346057
- Acronym / sponsor ID
- 8616-145
- Conditions
- Reversal of Neuromuscular Blockade
- Keywords
- arrhythmia, bradycardia, neuromuscular blocking agents, surgery, tachycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugammadex 2 mg/kg | Experimental | Drug: Sugammadex 2 mg/kg, Drug: Rocuronium, Drug: VecuroniumSugammadex 2 mg/kg administered as a single intravenous (IV) dose |
| Sugammadex 4 mg/kg | Experimental | Drug: Sugammadex 4 mg/kg, Drug: Rocuronium, Drug: VecuroniumSugammadex 4 mg/kg administered as a single IV dose |
| Sugammadex 16 mg/kg | Experimental | Drug: Sugammadex 16 mg/kg, Drug: RocuroniumSugammadex 16 mg/kg administered as a single IV dose |
| Neostigmine + Glycopyrrolate | Active comparator | Drug: Neostigmine + Glycopyrrolate, Drug: Rocuronium, Drug: VecuroniumNeostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a body mass index (BMI) < 40 kg/m2.
- Is categorized as ASA Physical Status Class 3 or 4, as determined by the Investigator.
- Has a planned surgical procedure that requires NMB with either rocuronium or vecuronium.
- Has a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case.
- If female who is not of reproductive potential, is one of the following: (1) postmenopausal; (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 (e.g., hysterectomy or tubal ligation) as the planned surgical procedure associated with participation in this study.
Key exclusion criteria (10 listed)
- Has a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.
- Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
- Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
- Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min.
- Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
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/kgAlso: MK-8616, BridionFollowing administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches. | Drug | Sugammadex 2 mg/kg |
| Sugammadex 4 mg/kgAlso: MK-8616, BridionFollowing administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 4 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction. | Drug | Sugammadex 4 mg/kg |
| Sugammadex 16 mg/kgAlso: MK-8616, BridionFollowing administration of NMBA (Rocuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 16 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction. | Drug | Sugammadex 16 mg/kg |
| 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) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches. | Drug | Neostigmine + Glycopyrrolate |
| RocuroniumTo achieve NMB, participants received steroidal NMBA Rocuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia. | Drug | Neostigmine + Glycopyrrolate, Sugammadex 16 mg/kg, Sugammadex 2 mg/kg, Sugammadex 4 mg/kg |
| VecuroniumTo achieve NMB, participants received steroidal NMBA Vecuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia. | Drug | Neostigmine + Glycopyrrolate, Sugammadex 2 mg/kg, Sugammadex 4 mg/kg |
Primary outcome
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
Time frame: Up to approximately 35 minutes post-administration
The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were 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 have been considered an adverse event (AE), as determined by investigator judgment.
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
Time frame: Up to approximately 35 minutes post-administration
The percentage of participants experiencing treatment-emergent sinus tachycardia events was 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 have been considered an AE, as determined by investigator judgment.
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
Time frame: Up to approximately 35 minutes post-administration
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.
Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention
Time frame: Up to 7 days
As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention
Time frame: Up to 7 days
As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention
Time frame: Up to 7 days
As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were 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. A participant could have experienced more than one type of ECI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34711192Herring WJ, Mukai Y, Wang A, Lutkiewicz J, Lombard JF, Lin L, Watkins M, Broussard DM, Blobner M. A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants. BMC Anesthesiol. 2021 Oct 28;21(1):259. doi: 10.1186/s12871-021-01477-5.
- 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
30 sites in 4 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, Sugammadex 4 mg/kg and Sugammadex 16 mg/kg in people with Reversal of Neuromuscular Blockade, run by Merck Sharp & Dohme LLC at 30 sites in 4 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 7 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Denmark, Austria, Germany. 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 8 Oct 2020). 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?
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events (time frame: Up to approximately 35 minutes post-administration). The study lists 6 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 NCT03346057, 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 8 Oct 2020.