Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)
Status and phase
Completed
Phase 2
Conditions
Anesthesia, General
Treatments
Drug: Sugammadex
Drug: Placebo
Drug: Esmeron®
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Full description
In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.
Enrollment
174 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Participants of ASA class 1 - 3, above or equal to the age of 18 years;
- Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
- Participants scheduled for surgical procedures in supine position;
- Participants who had given written informed consent.
Exclusion criteria
- Participants in whom a difficult intubation because of anatomical malformations was expected;
- Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;
- Participants known or suspected to have a (family) history of malignant hyperthermia;
- Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;
- Participants who had already participated in this trial;
- Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;
- Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
- Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence;
- Female participants who were breast-feeding.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
174 participants in 24 patient groups, including a placebo group
Arm A. Placebo; 3 min after 1 mg/kg Esmeron®
Placebo Comparator group
Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm G. Placebo; 15 min after 1 mg/kg Esmeron®
Placebo Comparator group
Description:
Placebo (single intravenous (IV) bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®
Placebo Comparator group
Description:
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron®
Placebo Comparator group
Description:
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental group
Description:
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Trial contacts and locations
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