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AzTrials

Anesthesia, GeneralPhase 3NCT00474253

Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)

A Phase 3 study testing Sugammadex, Succinylcholine and Rocuronium in people with Anesthesia, General, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anesthesia, General
What is being tested?
Sugammadex, Succinylcholine and Rocuronium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
No sites listed yet
Study dates
10 Feb 2006to 9 Sep 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
  • 18 to 65 years of age (inclusive);
  • Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
  • Scheduled for surgery in supine position;
  • Body mass index (BMI) < 30;
  • Given written informed consent.

Who cannot join

  • Has ischemic heart disease or history of myocardial infarction within the last year;
  • May experience difficult intubation due to anatomical malformations;
  • Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
  • Known or suspected family history of malignant hyperthermia;
  • Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
  • Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
Show all 10Show fewer
  • Individuals in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
  • Females who are pregnant or breast-feeding;
  • Females of childbearing potential who are not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
  • Has already participated in a sugammadex trial including Protocol 19.4.303.

About this study

Official title: A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.Kg-1 Rocuronium Followed by 16 mg.Kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.Kg-1 Succinylcholine

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

Being tested
Sugammadex, Succinylcholine, Rocuronium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SugammadexDrug

    Also called Org 25969, MK-8616

    Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex

  • SuccinylcholineDrug

    Single bolus IV dose of 1.0 mg/kg succinylcholine

  • RocuroniumDrug

    Also called Zemuron®

    Single bolus IV dose of 1.2 mg/kg rocuronium

Study groups in NCT00474253
Study groupRoleWhat they receive
Rocuronium + SugammadexExperimentalParticipants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex.
Receives: Drug: Sugammadex; Drug: Rocuronium
SuccinylcholineActive comparatorParticipants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.
Receives: Drug: Succinylcholine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration

    Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.

    Measured: Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine

Secondary outcomes (6)

  1. Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration

    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.

    Measured: Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine

  2. Level of Consciousness: Number of Participants Awake and Oriented

    The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness. The clinical level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.

    Measured: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

  3. Level of Consciousness: Number of Participants Arousable With Minimal Stimulation

    The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.

    Measured: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

  4. Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation

    The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.

    Measured: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

  5. Number of Participants Able to Perform 5-Second Head Lift

    The number of participants who were able to lift their head for 5 seconds was assessed as a measure of recovery following neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved.

    Measured: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

  6. Number of Participants Experiencing General Muscle Weakness

    The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups.

    Measured: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2007 (estimated)
  2. Study start10 Feb 2006
  3. Primary completion22 Aug 2006
  4. Study completion9 Sep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00474253
Sponsor's protocol ID
P05946
Other IDs
19.4.303, P05946, MK-8616-026
Status last verified
Mar 2019
First submitted
15 May 2007
Last updated
11 Apr 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0.

    PubMed 19387176

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sugammadex, Succinylcholine and Rocuronium in people with Anesthesia, General, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration (time frame: Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00474253, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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