Trial Outcomes & Findings for Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED) (NCT NCT00751179)

NCT ID: NCT00751179

Last Updated: 2015-06-30

Results Overview

Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 161 participants
• Primary outcome timeframe: Baseline and 5 minutes post dose
• Results posted on: 2015-06-30

Participant Flow

Participant milestones

Measure	Rocuronium - Sugammadex An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Overall Study STARTED	76	85
Overall Study COMPLETED	62	70
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

Baseline characteristics by cohort

Measure	Rocuronium - Sugammadex n=66 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=80 Participants An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.	Total n=146 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 13 • n=5 Participants	45 years STANDARD_DEVIATION 14 • n=7 Participants	43 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	53 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 5 minutes post dose

Population: Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.

Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=55 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=68 Participants An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine	-0.06 mmol/L Standard Deviation 0.32	0.30 mmol/L Standard Deviation 0.34

PRIMARY outcome

Timeframe: Baseline and 5 minutes post dose

Population: Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.

Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=53 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex	0.02 mmol/L Standard Deviation 0.42	—

SECONDARY outcome

Timeframe: Baseline and 2 minutes post dose

Population: Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.

Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=50 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=64 Participants An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine	-0.09 mmol/L Standard Deviation 0.30	0.19 mmol/L Standard Deviation 0.36

SECONDARY outcome

Timeframe: Baseline and 2 minutes post dose

Population: Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.

Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=49 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex	-0.02 mmol/L Standard Deviation 0.39	—

SECONDARY outcome

Timeframe: Baseline and 10 minutes post dose

Population: Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.

Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=56 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=62 Participants An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine	-0.01 mmol/L Standard Deviation 0.27	0.32 mmol/L Standard Deviation 0.41

SECONDARY outcome

Timeframe: Baseline and 10 minutes post dose

Population: Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.

Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=43 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex	0.07 mmol/L Standard Deviation 0.38	—

SECONDARY outcome

Timeframe: Baseline and 15 minutes post dose

Population: Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.

Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=55 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=65 Participants An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine	0.02 mmol/L Standard Deviation 0.26	0.33 mmol/L Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline and 15 minutes post dose

Population: Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.

Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

Outcome measures

Measure	Rocuronium - Sugammadex n=47 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex	0.07 mmol/L Standard Deviation 0.39	—

SECONDARY outcome

Timeframe: Up to 7 days post dose

Population: Participants who received sugammadex or succinylcholine.

Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered "pretreatment" events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).

Outcome measures

Measure	Rocuronium - Sugammadex n=66 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=80 Participants An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups	60 participants	75 participants

SECONDARY outcome

Timeframe: Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)

Population: Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.

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. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

Outcome measures

Measure	Rocuronium - Sugammadex n=59 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium	1.79 Minutes Interval 1.59 to 2.03	—

SECONDARY outcome

Timeframe: Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)

Population: Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.

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. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.

Outcome measures

Measure	Rocuronium - Sugammadex n=77 Participants An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine	10.76 Minutes Interval 10.06 to 11.52	—

Adverse Events

Rocuronium - Sugammadex

Serious events: 1 serious events

Other events: 57 other events

Deaths: 0 deaths

Succinylcholine

Serious events: 3 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rocuronium - Sugammadex n=66 participants at risk An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=80 participants at risk An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/66 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	1.2% 1/80 • Number of events 1 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Injury, poisoning and procedural complications Procedural nausea	1.5% 1/66 • Number of events 1 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	0.00% 0/80 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Investigations Medical observation	0.00% 0/66 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	1.2% 1/80 • Number of events 1 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Investigations Oxygen saturation decreased	0.00% 0/66 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	1.2% 1/80 • Number of events 1 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).

Other adverse events

Measure	Rocuronium - Sugammadex n=66 participants at risk An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.	Succinylcholine n=80 participants at risk An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Gastrointestinal disorders Abdominal pain	4.5% 3/66 • Number of events 5 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	6.2% 5/80 • Number of events 5 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Gastrointestinal disorders Nausea	19.7% 13/66 • Number of events 13 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	12.5% 10/80 • Number of events 10 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Gastrointestinal disorders Vomiting	10.6% 7/66 • Number of events 7 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	6.2% 5/80 • Number of events 5 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Injury, poisoning and procedural complications Incision site pain	7.6% 5/66 • Number of events 5 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	8.8% 7/80 • Number of events 8 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Injury, poisoning and procedural complications Procedural hypotension	3.0% 2/66 • Number of events 2 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	21.2% 17/80 • Number of events 20 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Injury, poisoning and procedural complications Procedural nausea	7.6% 5/66 • Number of events 5 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	3.8% 3/80 • Number of events 3 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Injury, poisoning and procedural complications Procedural pain	66.7% 44/66 • Number of events 46 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	62.5% 50/80 • Number of events 55 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
Musculoskeletal and connective tissue disorders Myalgia	1.5% 1/66 • Number of events 1 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).	6.2% 5/80 • Number of events 6 • Up to 7 days post dose Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: ClinicalTrialsDisclosure@merck.com

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