Clinical trial NCT00552929: A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)
Official title: A Multi -Center, Randomized, Open -Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-02
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial was to establish the dose-response relation of sugammadex given as a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during sevoflurane anesthesia for Caucasian participants


Eligibility criteria: Inclusion Criteria:

* Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
* Participants at least 20 years but under 65 years of age;
* Caucasian participants ;
* Participants scheduled for elective surgery requiring muscle relaxation 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 CT 19.4.209B, or in another trial with sugammadex;
* Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.

Primary outcomes:
measure: Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation
timeFrame: Up to 131:40 (min:sec)
Secondary outcomes:
measure: Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.7
timeFrame: Up to 96:24 (min:sec)
measure: Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.8
timeFrame: Up to 102:25 (min:sec)
measure: Number of Participants With An Adverse Event (AE)
timeFrame: From Screening to 7 post-operative days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.