Phase 3
Completed N=162
Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
Anesthesia, General
Source: ClinicalTrials.gov NCT00474617 ↗
Enrolled (actual)
162
Serious AEs
10.0%
Results posted
Mar 2019
Primary outcomePrimary: Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9 — 2.53; 2.92; 3.93 Minutes
◆ Published Evidence
Highly cited
120citations · ~8 / year
Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients.
Summary
The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.
Linked Publications
-
Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9 |
2.53; 2.92; 3.93 | — |
| SECONDARY Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 |
1.77; 2.10; 2.68 | — |
| SECONDARY Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8 |
2.05; 2.38; 3.10 | — |
| SECONDARY Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation |
24; 38; 21; 21; 22; 17 | — |
| SECONDARY Participants Level of Consciousness Prior to Discharge From Recovery Room |
43; 56; 36; 3; 2; 2 | — |
| SECONDARY Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation |
0; 3; 1 | — |
| SECONDARY Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room |
0; 0; 1 | — |
| SECONDARY Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation |
40; 57; 31 | — |
| SECONDARY Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room |
46; 58; 38 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Class 1 to 3
- 18 years of age or older
- Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
- Scheduled for surgery in supine position
- Given written informed consent
Exclusion Criteria
- Participants in whom a difficult intubation is expected due to anatomical malformations
- Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal 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 medications used during surgery
- Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
- Female participants who are pregnant or breast-feeding
- Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), intrauterine device (IUD), abstinence]
- Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
- Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305
Data sourced from ClinicalTrials.gov (NCT00474617) 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.