Reversal of neuromuscular blockade MedDRA version: 20.0 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Bridion (Sugammadex injection)
Product Name: Bridion
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SUGAMMADEX SODIUM
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male/Female subjects aged 18 years or older who are morbidly obese and: 1.Have BMI = 40 kg/m2 (morbidly obese). 2.Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 3, as determined by the Investigator 3.Have a planned surgical procedure that requires neuromuscular block with either rocuronium or vecuronium 4.Have a planned surgical procedure (e.g., gastrointestinal [GI], urologic, or laparoscopic procedures) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case (maintained by re-dosing or continuous infusion) 5.Have a planned surgical procedure that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring (NMTM) 6.If female, who is not of reproductive potential, be one of the following: (1) postmenopausal (defined as at least 12 months with no menses in women =45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; (3) has a congenital or acquired condition that prevents childbearing; or (4) is undergoing surgical sterilization as the planned surgical procedure associated with participation in this study (e.g., hysterectomy or tubal ligation). 7.If female, who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Medically accepted methods of contraception include condoms (male or female) with a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or copper - containing IUD, surgical sterilization (eg, hysterectomy or tubal ligation). Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post ovulation methods, etc.) and withdrawal are not acceptable methods of contraception. If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region. 8.Be able to provide (or the subject’s legally authorized representative in accordance with local requirements), written informed consent for the trial. The subject or legally authorized representative may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1.Has an actual body weight < 100 kg 2.Has a pacemaker or automatic implantable cardioverter-defibrillator (AICD) that precludes the assessment of bradycardia or arrhythmias 3.Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery 4.Has neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments 5.Is dialysis-dependent or has severe renal insufficiency (defined as estimated creatinine clearance of < 30 mL/min, based on results from local labs within the past 2 weeks prior to Visit 1 or labs performed between V1 and V2). 6.Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia 7.Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia 8.Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration 9.Has any condition that would contraindicate the administration of study medication 10.Is pregnant, is attempting to become pregnant, or is lactating 11.Has any clinically significant condition or situation (e.g., anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial 12.Is currently participating in or has participated in an interventional clinical trial with an investigational compound (including any other current or ongoing trial with a sugammadex treatment arm) or device within 30 days of signing the informed consent form of this current trial 13.Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The time to recovery to a TOF ratio of =0.9 for a comparison of actual body weight (ABW) and ideal body weight (IBW) dosing of sugammadex pooled across depth of block and neuromuscular blocking agent (NMBA); Main Objective: 1.To evaluate the efficacy of sugammadex when dosed according to actual body weight (ABW) as compared with ideal body weight (IBW); specifically, to compare the distributions of recovery times pooled across depth of block and neuromuscular blocking agent (NMBA) 2.To evaluate the safety of sugammadex when dosed according to ABW as compared with IBW pooled across depth of block and NMBA ; Secondary Objective: To evaluate the efficacy of sugammadex when dosed according to ABW as compared with IBW, by comparing: 1. The distributions of recovery times to TOFs (Train-of-Four Stimulation) of =0.7, =0.8, and =0.9 via mean, standard deviation and geometric mean pooled across both depth of block and NMBA 2.The proportions of subjects with prolonged recovery (>10 minutes) pooled across both depth of block and NMBA ; Timepoint(s) of evaluation of this end point: - To evaluate the efficacy of sugammadex. The time to recovery to a train-of-four (TOF) ratio of = 0.9 is faster in subjects dosed according to ABW as compared to subjects dosed according to IBW, pooled across depth of block and NMBA. - To evaluate the safety of sugammadex when dosed according to ABW as compared with IBW pooled across depth of block and NMBA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Distribution of time to recovery to a TOF ratio of =0.7, =0.8 and =0.9 as well as the proportions of subjects with prolonged recovery (>10 minutes) pooled across depth of block and NMBA.; Timepoint(s) of evaluation of this end point: To evaluate the efficacy of sugammadex when dosed according to ABW as compared with IBW, by comparing: a. The distributions of recovery times to TOFs of =0.7, =0.8, and =0.9 via mean, standard deviation and geometric mean pooled across both depth of block and NMBA b.The proportions of subjects with prolonged recovery (>10 minutes) pooled across both depth of block and NMBA | — |
Countries
Austria, Belgium, Denmark, Germany, United States
Outcome results
None listed