CompletedNCT00451217Updated Mar 4, 2019Results posted

Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

A Phase 3 interventional study of Sugammadex and Neostigmine in Anesthesia, General, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-04.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 1 year 4 months after the study started (first participant enrolled Nov 2005, registered Mar 2007).

Phase: Phase 3
Study type: Interventional
Enrollment: 198
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.

Conditions studied

Anesthesia, General

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Is of American Society of Anesthesiologists (ASA) 1 - 4;
Is above or equal to the age of 18;
Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
Scheduled for surgical procedure in supine position;
Given written informed consent.

Exclusion criteria

Exclusion Criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
Is known or suspected to have a (family) history of malignant hyperthermia;
Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
Had already participated in a sugammadex trial;
Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960.
Females who are pregnant:
Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
Females who were breast-feeding.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 198 participants (actual)

Study arms

Experimental
Rocuronium + Sugammadex
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
Drug: Sugammadex
Active comparator
Rocuronium + Neostigmine
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Drug: Neostigmine
Experimental
Vecuronium + Sugammadex
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
Drug: Sugammadex
Active comparator
Vecuronium + Neostigmine
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Drug: Neostigmine

Interventions

DrugSugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
Also known as: Org 25969
DrugNeostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Also known as: premix neostigmine/glycopyrrolate

What researchers measure

Primary outcomes

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
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 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9

Secondary outcomes

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
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 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
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 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time frame: Day 1
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time frame: Day 1

Results

Posted Feb 18, 2019

Participant flow

Participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.

Participant flow — Overall Study
Milestone	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Started	49	49	51	49
Treated	48	48	48	45
Completed	47	47	47	44
Not completed	2	2	4	5
Withdrew: Lost to follow-up	0	1	1	1
Withdrew: Withdrawal by subject	1	0	0	0
Withdrew: Not treated	1	1	3	4

Outcome measures

PrimaryTime From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.

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 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

Time frame:: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
Reported as:: Mean · Minutes

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
Minutes	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.	1.62 ± 0.83	26.78 ± 24.60	4.47 ± 9.28	23.43 ± 18.53

SecondaryTime From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7

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 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.

Time frame:: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7
Reported as:: Mean · Minutes

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
Minutes	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7	1.17 ± 0.40	9.60 ± 8.23	1.68 ± 0.57	9.52 ± 10.15

SecondaryTime From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8

Time frame:: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8
Reported as:: Mean · Minutes

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
Minutes	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8	1.32 ± 0.48	15.32 ± 14.38	2.12 ± 0.87	15.33 ± 13.37

SecondaryNumber of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation

After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness

Time frame:: Day 1
Reported as:: Count of participants · Participants

Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Participants	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Consciousness: Awake and oriented	30	35	29	26
Consciousness: Arousable with minimal stimulation	16	13	17	14
Consciousness: Responsive only to tactile stimuli	2	0	2	5
Able to perform the 5 second head lift	38	37	40	32
Has general muscle weakness	3	9	4	6

SecondaryNumber of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room

Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness

Time frame:: Day 1
Reported as:: Count of participants · Participants

Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Participants	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Consciousness: Awake and oriented	46	48	48	43
Consciousness: Arousable with minimal stimulation	1	0	0	1
Consciousness: Responsive only to tactile stimuli	0	0	0	0
Able to perform the 5 second head lift	47	48	48	44
Has general muscle weakness	0	0	0	0

Adverse events

Collected over Up to 7 days after sugammadex or neostigmine treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Rocuronium + Sugammadex	0/48 (0%)	2/48 (4.2%)	37/48 (77.1%)
Rocuronium + Neostigmine	0/48 (0%)	3/48 (6.3%)	40/48 (83.3%)
Vecuronium + Sugammadex	0/48 (0%)	0/48 (0%)	32/48 (66.7%)
Vecuronium + Neostigmine	0/45 (0%)	0/45 (0%)	35/45 (77.8%)

Most frequent serious events

Most frequent serious events
Event	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Post procedural haemorrhageInjury, poisoning and procedural complications	2/48	0/48	0/48	0/45
SubileusGastrointestinal disorders	0/48	1/48	0/48	0/45
Postoperative infectionInfections and infestations	0/48	1/48	0/48	0/45
Procedural complicationInjury, poisoning and procedural complications	0/48	1/48	0/48	0/45
Peripheral arterial occlusive diseaseVascular disorders	0/48	1/48	0/48	0/45
Peripheral ischaemiaVascular disorders	0/48	1/48	0/48	0/45

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine
Procedural painInjury, poisoning and procedural complications	21/48	16/48	18/48	16/45
NauseaGastrointestinal disorders	12/48	14/48	13/48	16/45
PainGeneral disorders	11/48	8/48	6/48	5/45
VomitingGastrointestinal disorders	9/48	6/48	5/48	5/45
Dry mouthGastrointestinal disorders	3/48	5/48	1/48	7/45
ConstipationGastrointestinal disorders	0/48	6/48	2/48	3/45
HeadacheNervous system disorders	3/48	2/48	3/48	5/45
Procedural hypotensionInjury, poisoning and procedural complications	1/48	5/48	0/48	3/45
Neuromuscular block prolongedInjury, poisoning and procedural complications	0/48	0/48	0/48	4/45
Procedural complicationInjury, poisoning and procedural complications	1/48	1/48	1/48	4/45

Baseline characteristics

All Participants As Treated

Age, Continuous
Age, Continuous(Years)	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine	Total
Mean	51 ± 16	48 ± 14	49 ± 16	50 ± 15	49 ± 15

Sex: Female, Male
Sex: Female, Male(Participants)	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine	Total
Female	17	24	22	24	87
Male	31	24	26	21	102

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine	Total
Hispanic or Latino	5	9	7	8	29
Not Hispanic or Latino	43	39	41	37	160
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Rocuronium + Sugammadex	Rocuronium + Neostigmine	Vecuronium + Sugammadex	Vecuronium + Neostigmine	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	1	0	0	0	1
White	46	48	48	45	187
More than one race	0	0	0	0	0
Unknown or Not Reported	1	0	0	0	1

Study locations

No study locations are listed for this record.

References and documents

Publications

Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, Rietbergen H, Alvarez-Gomez JA. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine: a multicenter, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):64-73. doi: 10.1213/ane.0b013e3181ac53c3. Epub 2009 Aug 27. PubMed 19713265 ↗
Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7. PubMed 20683334 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00451217
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Mar 23, 2007
Start date: Nov 17, 2005
Primary completion: Mar 6, 2006
Completion: Mar 6, 2006
Results posted: Feb 18, 2019
Last update: Mar 4, 2019

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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