Phase 3 N=182 Randomized Single-blind Treatment

Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)

Anesthesia, General

Bottom Line

View on ClinicalTrials.gov: NCT00473694 ↗

Enrolled (actual)

182

Serious AEs

4.5%

Results posted

Mar 2019

Primary outcome: Primary: Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium — 3.28; 55.50 Minutes — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sugammadex (Drug); neostigmine (Drug); vecuronium (Drug); rocuronium (Drug); glycopyrrolate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Nov 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium	3.28; 55.50	<0.0001 sig
PRIMARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium	8.73; 77.80	<0.0001 sig
SECONDARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium	2.27; 37.68	<0.0001 sig
SECONDARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium	4.10; 56.17	<0.0001 sig
SECONDARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium	2.65; 45.82	<0.0001 sig
SECONDARY Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium	5.55; 67.42	<0.0001 sig
SECONDARY Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)	26; 20; 27; 20; 34; 32	—
SECONDARY Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)	9; 11; 12; 8; 0; 1	—
SECONDARY Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)	2; 3; 7; 7; 0; 0	—
SECONDARY Number of Participants Able to Perform a 5-second Head Lift	33; 28; 36; 24; 34; 33	—
SECONDARY Number of Participants Experiencing General Muscle Weakness	3; 5; 4; 2; 2; 3	—

Summary

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesiologists (ASA) Class 1 to 4
18 years or older
Scheduled to undergo an elective surgical procedure under general anesthesia requiring the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block
Scheduled for surgery in supine position
Given written informed consent

Exclusion Criteria

Participants in whom a difficult intubation is expected due to anatomical malformations
Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
Known or suspected to have a (family) history of malignant hyperthermia
Known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during surgery
Receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics, and magnesium (Mg2+)
Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated
Female participants who are pregnant or breast-feeding
Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence]
Participants who had already participated in an Org 25969 trial
Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302

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Data sourced from ClinicalTrials.gov (NCT00473694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.