Trial Outcomes & Findings for Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029) (NCT NCT00474617)

Last Updated: 2019-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

162 participants

Primary outcome timeframe

up to 10 minutes from start of sugammadex

Results posted on

2019-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Participants 18 to 64 Years Old 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 second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.	Participants 65 to 74 Years Old 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.	Participants 75 Years and Older 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.
Overall Study STARTED	56	64	42
Overall Study Treated	48	62	40
Overall Study COMPLETED	48	61	40
Overall Study NOT COMPLETED	8	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants 18 to 64 Years Old n=48 Participants 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 T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.	Participants 65 to 74 Years Old n=62 Participants 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.	Participants 75 Years and Older n=40 Participants 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.	Total n=150 Participants Total of all reporting groups
Age, Continuous	45.5 Years STANDARD_DEVIATION 11.32 • n=5 Participants	69.2 Years STANDARD_DEVIATION 2.53 • n=7 Participants	80.1 Years STANDARD_DEVIATION 4.08 • n=5 Participants	64.5 Years STANDARD_DEVIATION 15.41 • n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	27 Participants n=7 Participants	24 Participants n=5 Participants	80 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	35 Participants n=7 Participants	16 Participants n=5 Participants	70 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 10 minutes from start of sugammadex

Population: All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=48 Participants 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.	Participants 65 to 74 Years Old n=62 Participants 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.	Participants 75 Years and Older n=40 Participants 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.
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9	2.53 Minutes Standard Deviation 1.35	2.92 Minutes Standard Deviation 1.63	3.93 Minutes Standard Deviation 1.67

SECONDARY outcome

Timeframe: up to 10 minutes from start of sugammadex

Population: All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=48 Participants 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.	Participants 65 to 74 Years Old n=62 Participants 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.	Participants 75 Years and Older n=40 Participants 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.
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7	1.77 Minutes Standard Deviation 0.78	2.10 Minutes Standard Deviation 1.47	2.68 Minutes Standard Deviation 1.17

SECONDARY outcome

Timeframe: up to 10 minutes from start of sugammadex

Population: All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=48 Participants 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.	Participants 65 to 74 Years Old n=62 Participants 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.	Participants 75 Years and Older n=40 Participants 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.
Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8	2.05 Minutes Standard Deviation 0.98	2.38 Minutes Standard Deviation 1.55	3.10 Minutes Standard Deviation 1.35

SECONDARY outcome

Timeframe: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

Population: All participants that received study drug, had at least 1 post-baseline efficacy measurement and had data available for endpoint.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=47 Participants 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.	Participants 65 to 74 Years Old n=61 Participants 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.	Participants 75 Years and Older n=40 Participants 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.
Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation Awake and oriented	24 Participants	38 Participants	21 Participants
Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation Arousable with minimal stimulation	21 Participants	22 Participants	17 Participants
Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation Responsive only to tactile stimulation	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Prior to Discharge from Recovery Room (up to 24 hours)

Population: All participants that received study drug and had at least 1 post-baseline efficacy measurement and had data available for endpoint

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=46 Participants 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.	Participants 65 to 74 Years Old n=58 Participants 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.	Participants 75 Years and Older n=38 Participants 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.
Participants Level of Consciousness Prior to Discharge From Recovery Room Arousable with minimal stimulation	3 Participants	2 Participants	2 Participants
Participants Level of Consciousness Prior to Discharge From Recovery Room Responsive only to tactile stimulation	0 Participants	0 Participants	0 Participants
Participants Level of Consciousness Prior to Discharge From Recovery Room Awake and oriented	43 Participants	56 Participants	36 Participants

SECONDARY outcome

Timeframe: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

Population: All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=45 Participants 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.	Participants 65 to 74 Years Old n=60 Participants 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.	Participants 75 Years and Older n=34 Participants 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.
Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation	0 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Prior to Discharge from Recovery Room (up to 24 hours)

Population: All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=46 Participants 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.	Participants 65 to 74 Years Old n=58 Participants 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.	Participants 75 Years and Older n=38 Participants 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.
Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

Population: All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=45 Participants 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.	Participants 65 to 74 Years Old n=60 Participants 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.	Participants 75 Years and Older n=34 Participants 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.
Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation	40 Participants	57 Participants	31 Participants

SECONDARY outcome

Timeframe: Prior to Discharge from Recovery Room (up to 24 hours)

Population: All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.

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.

Outcome measures

Outcome measures
Measure	Participants 18 to 64 Years Old n=46 Participants 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.	Participants 65 to 74 Years Old n=58 Participants 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.	Participants 75 Years and Older n=38 Participants 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.
Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room	46 Participants	58 Participants	38 Participants

Adverse Events

Participants 18 to 64 Years Old

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Participants 65 to 74 Years Old

Serious events: 8 serious events

Other events: 62 other events

Deaths: 0 deaths

Participants 75 Years and Older

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Publication restrictions are in place

Restriction type: OTHER

Measure	Participants 18 to 64 Years Old n=48 participants at risk 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.	Participants 65 to 74 Years Old n=62 participants at risk 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.	Participants 75 Years and Older n=40 participants at risk 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.
Blood and lymphatic system disorders Anaemia	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	2.5% 1/40 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Abdominal haematoma	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Abdominal hernia	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Intestinal perforation	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Mechanical ileus	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	2.5% 1/40 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.
General disorders Catheter related complication	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
General disorders Localised oedema	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
General disorders Pyrexia	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Infections and infestations Cellulitis	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Infections and infestations Device related infection	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Infections and infestations Sepsis	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Post procedural complication	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	2.5% 1/40 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Postoperative ileus	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Investigations Oxygen saturation decreased	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/62 • up to 7 days after administration of the study drug Population included all participants that received study drug.	2.5% 1/40 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.

Measure	Participants 18 to 64 Years Old n=48 participants at risk 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.	Participants 65 to 74 Years Old n=62 participants at risk 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.	Participants 75 Years and Older n=40 participants at risk 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.
Blood and lymphatic system disorders Anaemia	8.3% 4/48 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	11.3% 7/62 • Number of events 7 • up to 7 days after administration of the study drug Population included all participants that received study drug.	12.5% 5/40 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Cardiac disorders Tachycardia	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	10.0% 4/40 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Constipation	6.2% 3/48 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	11.3% 7/62 • Number of events 7 • up to 7 days after administration of the study drug Population included all participants that received study drug.	20.0% 8/40 • Number of events 8 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Diarrhoea	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	3.2% 2/62 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	10.0% 4/40 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Flatulence	4.2% 2/48 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	6.5% 4/62 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	5.0% 2/40 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Nausea	27.1% 13/48 • Number of events 14 • up to 7 days after administration of the study drug Population included all participants that received study drug.	25.8% 16/62 • Number of events 16 • up to 7 days after administration of the study drug Population included all participants that received study drug.	37.5% 15/40 • Number of events 16 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Gastrointestinal disorders Vomiting	14.6% 7/48 • Number of events 7 • up to 7 days after administration of the study drug Population included all participants that received study drug.	14.5% 9/62 • Number of events 9 • up to 7 days after administration of the study drug Population included all participants that received study drug.	12.5% 5/40 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.
General disorders Chills	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	10.0% 4/40 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.
General disorders Oedema peripheral	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	6.5% 4/62 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.
General disorders Pyrexia	10.4% 5/48 • Number of events 6 • up to 7 days after administration of the study drug Population included all participants that received study drug.	17.7% 11/62 • Number of events 12 • up to 7 days after administration of the study drug Population included all participants that received study drug.	15.0% 6/40 • Number of events 6 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	1.6% 1/62 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Incision site complication	8.3% 4/48 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Post procedural nausea	18.8% 9/48 • Number of events 9 • up to 7 days after administration of the study drug Population included all participants that received study drug.	9.7% 6/62 • Number of events 6 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Procedural hypertension	10.4% 5/48 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	10.0% 4/40 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Injury, poisoning and procedural complications Procedural pain	91.7% 44/48 • Number of events 49 • up to 7 days after administration of the study drug Population included all participants that received study drug.	91.9% 57/62 • Number of events 63 • up to 7 days after administration of the study drug Population included all participants that received study drug.	90.0% 36/40 • Number of events 41 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Metabolism and nutrition disorders Hypocalcaemia	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	11.3% 7/62 • Number of events 7 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Metabolism and nutrition disorders Hypokalaemia	4.2% 2/48 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	12.9% 8/62 • Number of events 8 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Metabolism and nutrition disorders Hypomagnesaemia	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	9.7% 6/62 • Number of events 6 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	8.1% 5/62 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Nervous system disorders Dizziness	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	6.5% 4/62 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	12.5% 5/40 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Nervous system disorders Headache	16.7% 8/48 • Number of events 8 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	17.5% 7/40 • Number of events 7 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Psychiatric disorders Anxiety	2.1% 1/48 • Number of events 1 • up to 7 days after administration of the study drug Population included all participants that received study drug.	6.5% 4/62 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Psychiatric disorders Confusional state	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Psychiatric disorders Insomnia	6.2% 3/48 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	3.2% 2/62 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	6.5% 4/62 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	0.00% 0/40 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	4.2% 2/48 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	4.8% 3/62 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Skin and subcutaneous tissue disorders Pruritus	10.4% 5/48 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.	3.2% 2/62 • Number of events 2 • up to 7 days after administration of the study drug Population included all participants that received study drug.	7.5% 3/40 • Number of events 3 • up to 7 days after administration of the study drug Population included all participants that received study drug.
Vascular disorders Hypertension	0.00% 0/48 • up to 7 days after administration of the study drug Population included all participants that received study drug.	6.5% 4/62 • Number of events 4 • up to 7 days after administration of the study drug Population included all participants that received study drug.	12.5% 5/40 • Number of events 5 • up to 7 days after administration of the study drug Population included all participants that received study drug.