A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Anesthesia, General

Treatments: Drug: Sugammadex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00591786

19.4.209A (Other Identifier)

P05957

2005-001133-15 (EudraCT Number)

MK-8616-031 (Other Identifier)

Details and patient eligibility

About

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.

Enrollment: 100 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
• Participants at least 20 years but under 65 years of age;
• Japanese participants;
• Participants scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5-3 hours;
• Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria

• Participants in whom a difficult intubation because of anatomical malformations was expected;
• Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic 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 expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
• Female participants who were pregnant;
• Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
• Participants who were breast-feeding;
• Participants who had already participated in study CT 19.4.209A, or in another trial with sugammadex;
• Participants who had participated in another clinical trial within 6 months of entering into study CT 19.4.209A.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 10 patient groups

Sugammadex 0.5 mg/kg (Rocuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 1.0 mg/kg (Rocuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 2.0 mg/kg (Rocuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 4.0 mg/kg (Rocuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 8.0 mg/kg (Rocuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.8 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 0.5 mg/kg (Vecuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 1.0 mg/kg (Vecuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 2.0 mg/kg (Vecuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 4.0 mg/kg (Vecuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex

Sugammadex 8.0 mg/kg (Vecuronium)

Experimental group

Description:

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 mg/kg sugammadex was administered IV.

Treatment:

Drug: Sugammadex