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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.311 | Other Identifier | Organon Protocol Number | |
| P05943 | Other Identifier | Schering-Plough Protocol Number | |
| MK-8616-023 | Other Identifier | Merck Protocol Number |
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The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9 | Mean time from start of MK-8616 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). | Up to approximately 30 minutes following administration of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7 | Mean time from start of MK-8616 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 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 0.7 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). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25157214 | Derived | Hudson ME, Rietbergen H, Chelly JE. Sugammadex is effective in reversing rocuronium in the presence of antibiotics. BMC Anesthesiol. 2014 Aug 15;14:69. doi: 10.1186/1471-2253-14-69. eCollection 2014. |
| Label | URL |
|---|---|
| Click here to access a synopsis of the study results. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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The trial was conducted in 19 trial sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population was all randomized and treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The analysis population was all randomized and treated participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9 | Mean time from start of MK-8616 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). | The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.9 efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Up to approximately 30 minutes following administration of study treatment |
Up to 7 days after study drug administration
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electromechanical dissociation | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Rocuronium | Drug | Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered. |
|
| Up to approximately 10 minutes following administration of study treatment |
| Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8 | Mean time from start of MK-8616 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 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 0.8 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). | Up to approximately 15 minutes following administration of study treatment |
| Clinical Assessment of Recovery - Participant's Level of Consciousness | The quality of recovery was assessed by asking the participant 40 questions from a validated Quality of Recovery Questionnaire (QoR-40). Participants were assessed for level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation), if applicable, by asking their name, if they are aware of where they are, and what day it is. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room. | Up to 24 hours |
| Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL) | 5-second head lift test was assessment of the ability of the participant to lift the head for 5 seconds and was performed by a blinded safety assessor. Tests were repeated every 15 minutes until the participant could successfully perform the 5-second head-lift. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room. | Up to 24 hours |
| Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW) | General muscle weakness check was assessed by the investigator. The assessment of general muscle weakness was based on a scale from 0-10, with 0 representing total paralysis, 1 signifying extreme impairment, 9 for close to no impairment, and 10 for normal muscle strength. Scores of 3, 4, 5, etc. denoted increasing muscle strength in approximately 10% increments. Scores of 9 and lower were denoted as GMW. Assessment 1 occurred prior to transfer to the recovery room after extubation and assessment 2 occurred prior to discharge from the recovery room. | Up to 24 hours |
| Participants did not receive treatment |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | The analysis population was all randomized and treated participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The analysis population was all randomized and treated participants. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Sugammadex | Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered. |
|
|
| Secondary | Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7 | Mean time from start of MK-8616 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 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 0.7 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). | The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.7 efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Up to approximately 10 minutes following administration of study treatment |
|
|
|
| Secondary | Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8 | Mean time from start of MK-8616 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 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 0.8 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). | The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.8 efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Up to approximately 15 minutes following administration of study treatment |
|
|
|
| Secondary | Clinical Assessment of Recovery - Participant's Level of Consciousness | The quality of recovery was assessed by asking the participant 40 questions from a validated Quality of Recovery Questionnaire (QoR-40). Participants were assessed for level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation), if applicable, by asking their name, if they are aware of where they are, and what day it is. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room. | The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
| Secondary | Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL) | 5-second head lift test was assessment of the ability of the participant to lift the head for 5 seconds and was performed by a blinded safety assessor. Tests were repeated every 15 minutes until the participant could successfully perform the 5-second head-lift. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room. | The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
| Secondary | Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW) | General muscle weakness check was assessed by the investigator. The assessment of general muscle weakness was based on a scale from 0-10, with 0 representing total paralysis, 1 signifying extreme impairment, 9 for close to no impairment, and 10 for normal muscle strength. Scores of 3, 4, 5, etc. denoted increasing muscle strength in approximately 10% increments. Scores of 9 and lower were denoted as GMW. Assessment 1 occurred prior to transfer to the recovery room after extubation and assessment 2 occurred prior to discharge from the recovery room. | The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
| 0 |
| 197 |
| 8 |
| 197 |
| 187 |
| 197 |
| Ileus | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Peroneal nerve injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Radiculitis brachial | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| Title | Measurements |
|---|---|
|
| Arousable with minimal stimulation - Assessment 2 |
|
| Responsive only to tactile stimulation - Assess. 1 |
|
| Responsive only to tactile stimulation - Assess. 2 |
|