Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03519867 | Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042) | PHASE2 | COMPLETED | 50 | — | — | Aug 1, 2004 | May 26, 2005 | Jan 31, 2019 | - | — |
The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
| Arm | Type | Description |
|---|---|---|
| 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced neuromuscular blockade (NMB) reaches 1 to 2 PTCs. |
| 2) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 3) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 4) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 5) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 6) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 7) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 8) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 9) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| Name | Type | Description |
|---|---|---|
| MK-8616 | DRUG | MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight. |
| Zemuron® | DRUG | Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight. |
Inclusion Criteria: * Has an ASA Class of 1 to 3 * Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron® Exclusion Criteria: * Is undergoing dental or neck surgery * Has anatomical malformation...