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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002518-23 | EudraCT Number | ||
| 19.4.316 | Other Identifier | Organon Protocol ID | |
| MK-8616-004 | Other Identifier | Merck Protocol ID |
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The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugammadex | Experimental | Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium |
|
| Placebo | Placebo Comparator | Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB. | From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26126940 | Result | Rahe-Meyer N, Berger C, Wittmann M, Solomon C, Abels EA, Rietbergen H, Reuter DA. Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery. Anaesthesist. 2015 Jul;64(7):506-12. doi: 10.1007/s00101-015-0048-0. Epub 2015 Jul 1. |
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Participants were recruited from 10 sites in Germany from November 2008 to May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium |
| FG001 | Placebo | Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium. |
| BG001 | Placebo | Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB. | The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times. | Posted | Geometric Mean | 95% Confidence Interval | minutes | From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes) |
Up to 7 days after administration of IMP
The All Subjects Treated Population consisted of all randomized participants who received IMP.
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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 | Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Procedural Complication | Injury, poisoning and procedural complications | MedDRA (12.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| 0.9% sodium chloride (NaCl) | Drug | At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of placebo (0.9% NaCl, volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion. |
|
|
| From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes) |
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB. | From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Sugammadex | Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium |
| OG001 | Placebo | Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium |
|
|
| Secondary | Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB. | The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times. | Posted | Geometric Mean | 95% Confidence Interval | minutes | From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes) |
|
|
|
| Secondary | Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB. | The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times. | Posted | Geometric Mean | 95% Confidence Interval | minutes | From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes) |
|
|
|
| 4 |
| 69 |
| 44 |
| 69 |
| EG001 | Placebo | Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium | 4 | 68 | 48 | 68 |
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA (12.1) |
|
| Lymphocele | Vascular disorders | MedDRA (12.1) |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.1) |
|
| Diverticular Perforation | Gastrointestinal disorders | MedDRA (12.1) |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (12.1) |
|
| Flatulence | Gastrointestinal disorders | MedDRA (12.1) |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) |
|
| Pyrexia | General disorders | MedDRA (12.1) |
|
| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA (12.1) |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (12.1) |
|
| Wound Complication | Injury, poisoning and procedural complications | MedDRA (12.1) |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) |
|
| Headache | Nervous system disorders | MedDRA (12.1) |
|
| Sleep Disorder | Psychiatric disorders | MedDRA (12.1) |
|
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |