Phase 3
Completed N=86
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
Anesthesia, General
Source: ClinicalTrials.gov NCT00475215 ↗
Enrolled (actual)
86
Serious AEs
9.1%
Results posted
Apr 2019
Primary outcomePrimary: Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease — 2.42; 2.1 Minutes
◆ Published Evidence
Established
55citations · ~4 / year
Use of sugammadex in patients with a history of pulmonary disease.
Summary
The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.
Linked Publications
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Use of sugammadex in patients with a history of pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease |
2.42; 2.1 | — |
| PRIMARY Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE) |
97.4; 94.7 | — |
| PRIMARY Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) |
0; 0 | — |
| SECONDARY Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease |
1.5; 1.35 | — |
| SECONDARY Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease |
1.8; 1.62 | — |
| SECONDARY Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation |
17; 22; 16; 13; 6; 2 | — |
| SECONDARY Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room |
38; 38; 1; 0; 0; 0 | — |
| SECONDARY Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation |
23; 29; 5; 5 | — |
| SECONDARY Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room |
39; 37; 0; 1 | — |
| SECONDARY General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation |
3; 4; 25; 30 | — |
| SECONDARY General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room |
4; 6; 35; 32 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Class 1 to 3;
- Has been diagnosed with or having a past history of pulmonary disease;
- Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
- Is scheduled for surgery in supine position;
- Has given written informed consent;
Exclusion Criteria
- Is expected to have a difficult intubation due to anatomical malformations;
- Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
- Has known or suspected of having a (family) history of malignant hyperthermia;
- Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
- Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
- Is a female who is pregnant or breast-feeding;
- Is a female of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence] or using only hormonal contraception as birth control;
- Has already participated in a sugammadex trial including Protocol 19.4.308;
- Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.
Data sourced from ClinicalTrials.gov (NCT00475215) and the linked publication. 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.