Phase 2
Completed N=99
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
Neuromuscular Blockade
Source: ClinicalTrials.gov NCT03519854 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 — 52.05; 22.73; 4.93; 6.25 minutes
Summary
This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 |
52.05; 22.73; 4.93; 6.25; 1.85; 1.83 | — |
| SECONDARY Mean Heart Rate at Baseline |
61.0; 62.0; 63.5; 68.0; 68.2; 69.8 | — |
| SECONDARY Mean Heart Rate at 2 Minutes Following Administration of Study Treatment |
76.7; 73.0; 84.5; 72.7; 86.2; 74.8 | — |
| SECONDARY Mean Heart Rate at 30 Minutes Following Administration of Study Treatment |
77.8; 62.0; 72.0; 72.5; 76.7; 66.6 | — |
| SECONDARY Mean Corrected QT Interval (QTc) at Baseline |
418; 396; 418; 404; 417; 416 | — |
| SECONDARY Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment |
420; 406; 422; 406; 427; 416 | — |
| SECONDARY Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment |
418; 416; 427; 415; 433; 424 | — |
| SECONDARY Number of Participants Experiencing an Adverse Event |
0; 5; 1; 4; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Participants of ASA class 1 to 2.
- Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.
Exclusion Criteria
- Participants in whom a difficult intubation because of anatomical malformations is expected.
- Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.
- Participants known or suspected to have a (family) history of malignant hyperthermia.
- Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.
- Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.
- Participants who have already participated in this trial.
- Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.
Data sourced from ClinicalTrials.gov (NCT03519854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.