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Completed

NCT Number: NCT03519854

Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants of ASA class 1 to 2.
  • Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Exclusion criteria

  • Participants in whom a difficult intubation because of anatomical malformations is expected.
  • Participants known or suspected to have neuromuscular disorders and/or significant hepatic or 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 medication used during general anesthesia.
  • Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.
  • Participants who have already participated in this trial.
  • Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.

Treatment and study plan

Placebo

Drug

0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).

Sugammadex

Drug

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Other names: Org 25969; MK-8616; Bridion®.

Esmeron®

Drug

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Other names: Rocuronium bromide

Primary outcomes

  1. Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9

    Time frame: Up to 70 minutes following administration of study treatment

    Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

Secondary outcomes

  1. Mean Heart Rate at Baseline

    Time frame: Up to 45 minutes prior to study treatment administration

    Mean heart rate at baseline was assessed. Baseline heart rate was defined as the heart rate measured under stable anesthesia prior to administration of study treatment.

  2. Mean Heart Rate at 2 Minutes Following Administration of Study Treatment

    Time frame: 2 minutes following administration of study treatment

    Mean heart rate at 2 minutes following administration of study treatment was assessed.

  3. Mean Heart Rate at 30 Minutes Following Administration of Study Treatment

    Time frame: 30 minutes following administration of study treatment

    Mean heart rate at 30 minutes following administration of study treatment was assessed.

  4. Mean Corrected QT Interval (QTc) at Baseline

    Time frame: Up to 45 minutes prior to study treatment administration

    Mean QTc interval at baseline was assessed. Baseline QTc interval was defined as the QTc interval measured under stable anesthesia prior to administration of study treatment. The baseline QTc interval is corrected for participant heart rate at baseline prior to study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.

  5. Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment

    Time frame: 2 minutes following administration of study treatment

    Mean QTc interval at 2 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 2 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.

  6. Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment

    Time frame: 30 minutes following administration of study treatment

    Mean QTc interval at 30 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 30 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.

  7. Number of Participants Experiencing an Adverse Event

    Time frame: Up to 7 days following administration of study treatment

    The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multi-center, Randomized, Assessor-blinded, Placebo Controlled, Phase II, Parallel Dose-finding Trial in Male Subjects of ASA 1-2 to Assess the Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 When Administered After 0.6 mg.Kg-1 Esmeron® at 3, 5 or 15 Minutes

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
May 9, 2018
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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