Phase 2
Completed N=100
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)
Anesthesia, General
Source: ClinicalTrials.gov NCT00591409 ↗
Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Feb 2019
Primary outcomePrimary: Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 — 82.08; 3.95; 2.48; 2.17 Minutes
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 |
82.08; 3.95; 2.48; 2.17; 1.85; 83.20 | — |
| SECONDARY Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7 |
52.60; 2.35; 1.73; 1.23; 1.20; 85.85 | — |
| SECONDARY Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8 |
63.67; 2.70; 1.87; 1.50; 1.32; 68.40 | — |
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
Data sourced from ClinicalTrials.gov (NCT00591409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.