Phase 2
Completed N=100
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
Anesthesia, General
Source: ClinicalTrials.gov NCT00552617 ↗
Enrolled (actual)
100
Serious AEs
3.1%
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 — 96.30; 16.30; 4.62; 1.43 Minutes
Summary
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 reappearance 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) during sevoflurane anesthesia for Caucasian 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 |
96.30; 16.30; 4.62; 1.43; 1.50; 79.02 | — |
| SECONDARY Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7 |
65.67; 3.08; 2.08; 1.12; 1.02; 58.12 | — |
| SECONDARY Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8 |
75.85; 6.25; 2.62; 1.28; 1.15; 64.33 | — |
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;
- Caucasian participants;
- Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia 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 neuromuscular blocking (NMB) 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 of childbearing potential not using birth control or using only oral contraception as birth control;
- Was breast-feeding;
- Has already participated in P05971, or in another trial with sugammadex;
- Has participated in another clinical trial, not preapproved by the Sponsor, within 6 months of entering into P05971.
Data sourced from ClinicalTrials.gov (NCT00552617). 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.