Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

Anesthesia, General Clinical Trial

Official title:

A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474617
• Other study ID #: P05950
• Secondary ID: 19.4.305P05950MK
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2005
• Est. completion date: October 20, 2006

Study information

• Verified date: March 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 20, 2006
• Est. primary completion date: October 20, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• Sugammadex

• Rocurium
intravenous (IV) single bolus dose of 0.6 mg.kg-1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

McDonagh DL, Benedict PE, Kovac AL, Drover DR, Brister NW, Morte JB, Monk TG. Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients. Anesthesiology. 2011 Feb;114(2):318-29. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9	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	Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7	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
Secondary	Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8	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
Secondary	Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation	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)
Secondary	Participants Level of Consciousness Prior to Discharge From Recovery Room	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)
Secondary	Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation	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)
Secondary	Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room	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)
Secondary	Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation	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)
Secondary	Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room	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)

External Links

•   Click here to access a synopsis of the study results.