A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)

NCT ID: NCT00591409

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-03
• Study Completion Date: 2006-12-18

Brief Summary

The objective of this trial was to establish the dose-response 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) in Japanese and Caucasian participants. Part A: Japanese Participants

Detailed Description

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex (Org 25969) has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium-induced neuromuscular blockade. The current trial P05956 was conducted in Japan and set up to establish the dose-response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Japanese participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were evaluated.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rocuronium + Placebo

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 T2 a single dose of placebo was administered IV.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of placebo IV was administered

Rocuronium + 0.5 mg/kg sugammadex

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 T2 a single dose of 0.5 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Rocuronium + 1.0 mg/kg sugammadex

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 T2 a single dose of 1.0 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Rocuronium + 2.0 mg/kg sugammadex

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 T2 a single dose of 2.0 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Rocuronium + 4.0 mg/kg sugammadex

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 T2 a single dose of 4.0 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Vecuronium + Placebo

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of placebo IV was administered

Vecuronium + 0.5 mg/kg sugammadex

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Vecuronium + 1.0 mg/kg sugammadex

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Vecuronium + 2.0 mg/kg sugammadex

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Vecuronium + 4.0 mg/kg sugammadex

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Interventions

sugammadex

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.

Intervention Type: DRUG

Placebo

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of placebo IV was administered

Intervention Type: DRUG

Other Intervention Names

Org 25969

Eligibility Criteria

Inclusion Criteria

• Is of American Society of Anesthesiologists (ASA) class 1 - 3;
• Is at least 20 years but under 65 years of age;
• Japanese participants;
• Is scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of neuromuscular blocking agents (NMBAs), with an anticipated duration of about 1.5-3 hours;
• Has given written informed consent.

Exclusion Criteria

• Participants in whom a difficult intubation because of anatomical malformations was expected;
• Is known or suspected to have neuromuscular disorders impairing the effect of NMBAs and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic 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 expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
• Females who were pregnant;
• Females not using birth control or using only oral contraception as birth control continuously;
• Were breast-feeding;
• Has already participated in P05956, or in another trial with sugammadex;
• Has participated in another clinical trial within 6 months of entering into P05956

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Takeda J, Iwasaki H, Yamakage M, Ozaki M, Kawamata M, Hatano Y, Yorozuya T, Miyakawa H, Kanmura Y. [Efficacy and safety of sugammadex (Org 25969) in reversing moderate neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1075-82. Japanese.

Reference Type: BACKGROUND

PMID: 25693332 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Related Links

http://www.merck.com/clinical-trials/policies-perspectives.html

Click here to access a synopsis of the study results.

Other Identifiers

19.4.208A

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8616-030

Identifier Type: OTHER

Identifier Source: secondary_id

P05956

Identifier Type: -

Identifier Source: org_study_id