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

NCT00591409 | Completed Phase 2 Results

• 3 other identifiers: P0595619.4.208AMK-8616-030
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9

  Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

  Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)

Secondary Outcomes (2)

• Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7

  Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)

• Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8

  Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)

Study Arms (10)

Rocuronium + Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Rocuronium + 0.5 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Rocuronium + 1.0 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Rocuronium + 2.0 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Rocuronium + 4.0 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Vecuronium + Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Vecuronium + 0.5 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Vecuronium + 1.0 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Vecuronium + 2.0 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Vecuronium + 4.0 mg/kg sugammadex

EXPERIMENTAL

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.

Drug: sugammadex

Interventions

sugammadex 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.

Also known as: Org 25969

Rocuronium + 0.5 mg/kg sugammadex; Rocuronium + 1.0 mg/kg sugammadex; Rocuronium + 2.0 mg/kg sugammadex; Rocuronium + 4.0 mg/kg sugammadex; Vecuronium + 0.5 mg/kg sugammadex; Vecuronium + 1.0 mg/kg sugammadex; Vecuronium + 2.0 mg/kg sugammadex; Vecuronium + 4.0 mg/kg sugammadex

Placebo 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 + Placebo; Vecuronium + Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25693332 BACKGROUND

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: January 3, 2006
• Primary Completion: September 22, 2006
• Study Completion: December 18, 2006
• Last Updated: March 1, 2019
• Results First Posted: February 8, 2019

Record last verified: 2019-02