Clinical trial NCT00473694: 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)
Official title: A Multicenter, Randomized, Parallel Group Comparative, Active-Controlled, Safety-assessor Blinded. Phase IIIa, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a Neuromuscular Block Induced by Maintenance Dosing of Rocuronium or Vecuronium at 1-2 PTCs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: 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
timeFrame: Up to approximately 3 hours after administration of study drug
measure: 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
timeFrame: Up to approximately 6 hours after administration of study drug
Secondary outcomes:
measure: 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
timeFrame: Up to approximately 2 hours after administration of study drug
measure: 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
timeFrame: Up to approximately 4 hours after administration of study drug
measure: 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
timeFrame: Up to approximately 3 hours after administration of study drug
measure: 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
timeFrame: Up to approximately 5 hours after administration of study drug
measure: Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)
timeFrame: Up to 24 hours
measure: Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
timeFrame: Up to 24 hours
measure: Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
timeFrame: Up to 24 hours
measure: Number of Participants Able to Perform a 5-second Head Lift
timeFrame: Up to 24 hours
measure: Number of Participants Experiencing General Muscle Weakness
timeFrame: Up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Lemmens HJ, El-Orbany MI, Berry J, Morte JB Jr, Martin G. Reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia: sugammadex versus neostigmine. BMC Anesthesiol. 2010 Sep 1;10:15. doi: 10.1186/1471-2253-10-15.
citation: Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.