A Phase 3 interventional study of Sugammadex and 0.9% sodium chloride (NaCl) in Anesthesia and Neuromuscular Blockade, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-21.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Drug: Sugammadex
Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Drug: 0.9% sodium chloride (NaCl)
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.
Also known as: Org 25969, SCH 900616, MK-8616, Bridion®
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.
Also known as: Placebo
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.
Time frame: From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)
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.
Time frame: 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.
Time frame: From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)
Participants were recruited from 10 sites in Germany from November 2008 to May 2009.
| Milestone | Sugammadex | Placebo |
|---|---|---|
| Started | 70 | 70 |
| Treated | 69 | 68 |
| Completed | 69 | 67 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Not treated | 1 | 2 |
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.
| minutes | Sugammadex | Placebo |
|---|---|---|
| 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 | 2.2 (1.9 to 2.5) | 89.8 (80.1 to 100.7) |
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.
| minutes | Sugammadex | Placebo |
|---|---|---|
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 | 1.6 (1.4 to 1.8) | 70.1 (62.7 to 78.4) |
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.
| minutes | Sugammadex | Placebo |
|---|---|---|
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 | 1.8 (1.6 to 2.0) | 78.8 (70.2 to 88.5) |
Collected over Up to 7 days after administration of IMP. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugammadex | — | 4/69 (5.8%) | 44/69 (63.8%) |
| Placebo | — | 4/68 (5.9%) | 48/68 (70.6%) |
| Event | Sugammadex | Placebo |
|---|---|---|
| Post Procedural ComplicationInjury, poisoning and procedural complications | 1/69 | 1/68 |
| Post Procedural HaemorrhageInjury, poisoning and procedural complications | 1/69 | 1/68 |
| Diverticular PerforationGastrointestinal disorders | 0/69 | 1/68 |
| Skin LacerationInjury, poisoning and procedural complications | 0/69 | 1/68 |
| Alcohol Withdrawal SyndromePsychiatric disorders | 1/69 | 0/68 |
| LymphoceleVascular disorders | 1/69 | 0/68 |
| Event | Sugammadex | Placebo |
|---|---|---|
| Procedural PainInjury, poisoning and procedural complications | 29/69 | 32/68 |
| NauseaGastrointestinal disorders | 9/69 | 11/68 |
| Wound ComplicationInjury, poisoning and procedural complications | 11/69 | 10/68 |
| FlatulenceGastrointestinal disorders | 4/69 | 7/68 |
| HeadacheNervous system disorders | 7/69 | 5/68 |
| ConstipationGastrointestinal disorders | 6/69 | 4/68 |
| VomitingGastrointestinal disorders | 5/69 | 5/68 |
| DizzinessNervous system disorders | 1/69 | 5/68 |
| PyrexiaGeneral disorders | 4/69 | 4/68 |
| Procedural NauseaInjury, poisoning and procedural complications | 3/69 | 4/68 |
| Age, Continuous(years) | Sugammadex | Placebo | Total |
|---|---|---|---|
| Mean | 57 ± 17 | 57 ± 14 | 57 ± 16 |
| Sex: Female, Male(Participants) | Sugammadex | Placebo | Total |
|---|---|---|---|
| Female | 21 | 25 | 46 |
| Male | 48 | 43 | 91 |
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Merck Sharp & Dohme LLC