Trial Outcomes & Findings for Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026) (NCT NCT00474253)

NCT ID: NCT00474253

Last Updated: 2019-04-11

Results Overview

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 115 participants
• Primary outcome timeframe: Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine
• Results posted on: 2019-04-11

Participant Flow

Participant milestones

Measure	Rocuronium + Sugammadex Participants received a single bolus intravenous (IV) dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg three minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Overall Study STARTED	58	57
Overall Study Treated	56	54
Overall Study COMPLETED	55	53
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Rocuronium + Sugammadex Participants received a single bolus intravenous (IV) dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg three minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Overall Study Withdrew consent	2	0
Overall Study Withdrew due to surgery-related issues	0	3
Overall Study Lost to Follow-up	1	0
Overall Study Discharged prior to study completion	0	1

Baseline Characteristics

Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)

Baseline characteristics by cohort

Measure	Rocuronium + Sugammadex n=56 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=54 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.	Total n=110 Participants Total of all reporting groups
Age, Continuous	42 Years STANDARD_DEVIATION 13 • n=93 Participants	41 Years STANDARD_DEVIATION 13 • n=4 Participants	42 Years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	31 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment and had at least one post-baseline efficacy assessment

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.

Outcome measures

Measure	Rocuronium + Sugammadex n=54 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=53 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration	4.35 Minutes Standard Deviation 0.72	7.15 Minutes Standard Deviation 1.55

SECONDARY outcome

Timeframe: Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment and had at least one post-baseline efficacy assessment

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.

Outcome measures

Measure	Rocuronium + Sugammadex n=54 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=53 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration	6.13 Minutes Standard Deviation 1.78	11.03 Minutes Standard Deviation 2.40

SECONDARY outcome

Timeframe: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations

The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness. The clinical level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.

Outcome measures

Measure	Rocuronium + Sugammadex n=32 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=41 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Level of Consciousness: Number of Participants Awake and Oriented Prior to transfer to recovery room	8 Participants	13 Participants
Level of Consciousness: Number of Participants Awake and Oriented Prior to discharge from recovery room	19 Participants	33 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations

The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.

Outcome measures

Measure	Rocuronium + Sugammadex n=32 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=41 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Level of Consciousness: Number of Participants Arousable With Minimal Stimulation Prior to transfer to recovery room	7 Participants	15 Participants
Level of Consciousness: Number of Participants Arousable With Minimal Stimulation Prior to discharge from recovery room	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations

The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.

Outcome measures

Measure	Rocuronium + Sugammadex n=32 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=41 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation Prior to transfer to recovery room	5 Participants	7 Participants
Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation Prior to discharge from recovery room	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations

The number of participants who were able to lift their head for 5 seconds was assessed as a measure of recovery following neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved.

Outcome measures

Measure	Rocuronium + Sugammadex n=32 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=41 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Number of Participants Able to Perform 5-Second Head Lift Prior to transfer to recovery room	13 Participants	24 Participants
Number of Participants Able to Perform 5-Second Head Lift Prior to discharge from recovery room	20 Participants	35 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Population: All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations

The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups.

Outcome measures

Measure	Rocuronium + Sugammadex n=32 Participants Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=41 Participants Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Number of Participants Experiencing General Muscle Weakness Prior to transfer to recovery room	2 Participants	3 Participants
Number of Participants Experiencing General Muscle Weakness Prior to discharge from recovery room	0 Participants	0 Participants

Adverse Events

Rocuronium + Sugammadex

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Succinylcholine

Serious events: 1 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rocuronium + Sugammadex n=56 participants at risk Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=54 participants at risk Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/56 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	1.9% 1/54 • Number of events 1 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment

Other adverse events

Measure	Rocuronium + Sugammadex n=56 participants at risk Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block.	Succinylcholine n=54 participants at risk Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block.
Blood and lymphatic system disorders Anaemia	5.4% 3/56 • Number of events 3 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	5.6% 3/54 • Number of events 3 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Gastrointestinal disorders Abdominal pain	3.6% 2/56 • Number of events 2 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	5.6% 3/54 • Number of events 4 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Gastrointestinal disorders Constipation	3.6% 2/56 • Number of events 2 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	7.4% 4/54 • Number of events 5 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Gastrointestinal disorders Nausea	28.6% 16/56 • Number of events 20 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	37.0% 20/54 • Number of events 23 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Gastrointestinal disorders Vomiting	16.1% 9/56 • Number of events 9 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	14.8% 8/54 • Number of events 8 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
General disorders Chills	10.7% 6/56 • Number of events 6 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	13.0% 7/54 • Number of events 7 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
General disorders Pyrexia	8.9% 5/56 • Number of events 6 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	9.3% 5/54 • Number of events 8 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Injury, poisoning and procedural complications Incision site complication	8.9% 5/56 • Number of events 5 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	13.0% 7/54 • Number of events 10 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Injury, poisoning and procedural complications Procedural complication	8.9% 5/56 • Number of events 7 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	7.4% 4/54 • Number of events 4 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Injury, poisoning and procedural complications Procedural hypertension	12.5% 7/56 • Number of events 8 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	13.0% 7/54 • Number of events 7 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Injury, poisoning and procedural complications Procedural hypotension	12.5% 7/56 • Number of events 7 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	24.1% 13/54 • Number of events 14 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Injury, poisoning and procedural complications Procedural pain	57.1% 32/56 • Number of events 34 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	48.1% 26/54 • Number of events 26 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 3/56 • Number of events 4 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	11.1% 6/54 • Number of events 10 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	10.7% 6/56 • Number of events 8 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	13.0% 7/54 • Number of events 9 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Nervous system disorders Dizziness	7.1% 4/56 • Number of events 4 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	3.7% 2/54 • Number of events 2 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Nervous system disorders Headache	14.3% 8/56 • Number of events 9 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	3.7% 2/54 • Number of events 2 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Nervous system disorders Hypoaesthesia	5.4% 3/56 • Number of events 3 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	3.7% 2/54 • Number of events 3 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Psychiatric disorders Anxiety	5.4% 3/56 • Number of events 3 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	1.9% 1/54 • Number of events 1 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Psychiatric disorders Insomnia	8.9% 5/56 • Number of events 5 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	5.6% 3/54 • Number of events 4 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Renal and urinary disorders Urinary retention	3.6% 2/56 • Number of events 2 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	7.4% 4/54 • Number of events 4 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.4% 3/56 • Number of events 3 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment	3.7% 2/54 • Number of events 2 • Up to 7 days after administration of rocuronium + sugammadex or succinylcholine All participants who received study treatment

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning this clinical trial 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