Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
March 25, 2019 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Other Names:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
Experimental: 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.
|
Other Names:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
Experimental: 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.
|
Other Names:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2005
Primary Completion (Actual)
October 20, 2006
Study Completion (Actual)
October 20, 2006
Study Registration Dates
First Submitted
May 15, 2007
First Submitted That Met QC Criteria
May 15, 2007
First Posted (Estimate)
May 17, 2007
Study Record Updates
Last Update Posted (Actual)
April 2, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- P05950 (Other Identifier: Schering-Plough Study Number)
- 19.4.305 (Other Identifier: Organon Study Number)
- MK-8616-029 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.