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OpenTrials
Completed

NCT Number: NCT00474617

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Other names: Org 25969; MK-8616

Rocurium

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 17, 2007
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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