Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

Study Overview
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Brief Summary
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The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

Official Title
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A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Rocurium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) Class 1 to 3 18 years of age or older Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium Scheduled for surgery in supine position Given written informed consent Exclusion Criteria: Participants in whom a difficult intubation is expected due to anatomical malformations Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant 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 medications used during surgery Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium Female participants who are pregnant or breast-feeding Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), intrauterine device (IUD), abstinence] Participants who had already participated in a Org 25969 trial including Protocol 19.4.305 Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants 18 to 64 years old<br>Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. | Drug: Sugammadex<br> <br> * Other names: Org 25969; MK-8616;Drug: Rocurium<br>* intravenous (IV) single bolus dose of 0.6 mg.kg-1<br>|
| Experimental: Participants 65 to 74 years old<br>Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. | Drug: Sugammadex<br> <br> * Other names: Org 25969; MK-8616;Drug: Rocurium<br>* intravenous (IV) single bolus dose of 0.6 mg.kg-1<br>|
| Experimental: Participants 75 years and older<br>Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. | Drug: Sugammadex<br> <br> * Other names: Org 25969; MK-8616;Drug: Rocurium<br>* intravenous (IV) single bolus dose of 0.6 mg.kg-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | up to 10 minutes from start of sugammadex | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | up to 10 minutes from start of sugammadex | 
| Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | up to 10 minutes from start of sugammadex | 
| Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation | Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized. | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) | 
| Participants Level of Consciousness Prior to Discharge From Recovery Room | Participants level of consciousness was assessed prior to discharge from the recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized. | Prior to Discharge from Recovery Room (up to 24 hours) | 
| Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as yes or no to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) | 
| Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as yes or no to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Discharge from Recovery Room (up to 24 hours) | 
| Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation | Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) | 
| Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room | Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Discharge from Recovery Room (up to 24 hours) |