Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
2019年3月25日 更新者：Merck Sharp & Dohme LLC
A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects
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.
調査の概要
研究の種類
介入
入学 (実際)
162
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Participants 18 to 64 years old
Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium.
If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered.
After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
|
他の名前：
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
実験的：Participants 65 to 74 years old
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium.
If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered.
After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
|
他の名前：
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
実験的：Participants 75 years and older
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium.
If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered.
After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
|
他の名前：
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
時間枠：up to 10 minutes from start of sugammadex
|
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9.
A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
|
up to 10 minutes from start of sugammadex
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
時間枠：up to 10 minutes from start of sugammadex
|
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7.
A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
|
up to 10 minutes from start of sugammadex
|
|
Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8
時間枠：up to 10 minutes from start of sugammadex
|
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8.
A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
|
up to 10 minutes from start of sugammadex
|
|
Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation
時間枠：Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
|
Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room.
The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation.
The number of participants in each of the 3 categories was summarized.
|
Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
|
|
Participants Level of Consciousness Prior to Discharge From Recovery Room
時間枠：Prior to Discharge from Recovery Room (up to 24 hours)
|
Participants level of consciousness was assessed prior to discharge from the recovery room.
The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation.
The number of participants in each of the 3 categories was summarized.
|
Prior to Discharge from Recovery Room (up to 24 hours)
|
|
Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation
時間枠：Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
|
The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room.
A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness.
Participants who were not cooperative with the examination were not included in the assessment.
|
Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
|
|
Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room
時間枠：Prior to Discharge from Recovery Room (up to 24 hours)
|
The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room.
A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness.
Participants who were not cooperative with the examination were not included in the assessment.
|
Prior to Discharge from Recovery Room (up to 24 hours)
|
|
Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation
時間枠：Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
|
Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room.
The number of participants who could perform the 5 second head lift was summarized.
Participants who were not cooperative with the examination were not included in the assessment.
|
Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
|
|
Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room
時間枠：Prior to Discharge from Recovery Room (up to 24 hours)
|
Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room.
The number of participants who could perform the 5 second head lift was summarized.
Participants who were not cooperative with the examination were not included in the assessment.
|
Prior to Discharge from Recovery Room (up to 24 hours)
|
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出版物と役立つリンク
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2005年12月29日
一次修了 (実際)
2006年10月20日
研究の完了 (実際)
2006年10月20日
試験登録日
最初に提出
2007年5月15日
QC基準を満たした最初の提出物
2007年5月15日
最初の投稿 (見積もり)
2007年5月17日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月2日
QC基準を満たした最後の更新が送信されました
2019年3月25日
最終確認日
2019年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- P05950 (その他の識別子：Schering-Plough Study Number)
- 19.4.305 (その他の識別子：Organon Study Number)
- MK-8616-029 (その他の識別子：Merck Protocol Number)
個々の参加者データ (IPD) の計画
試験データ・資料
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。