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Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile (Neuropa)

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ClinicalTrials.gov Identifier: NCT02243943
Recruitment Status : Completed
First Posted : September 18, 2014
Results First Posted : August 25, 2016
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Albert Dahan, Leiden University Medical Center

Brief Summary:
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.

Condition or disease Intervention/treatment Phase
Postoperative Respiratory Condition Drug: Sugammadex Drug: Neostigmine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sugammadex
Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Drug: Sugammadex
Other Name: Bridion

Active Comparator: neostigmine
subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Drug: Neostigmine
Other Name: Prostigmin




Primary Outcome Measures :
  1. Mean Lowest Saturation [ Time Frame: 45 minutes post surgery ]
    Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery


Secondary Outcome Measures :
  1. Pain [ Time Frame: 45 minutes post surgery ]
    using the 1-10 numeric rating scale

  2. Sedation [ Time Frame: 45 minutes post surgery ]
    using the Leiden observer alertness score (1 alert - 5 sedated)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years
  • ‐ BMI < 35
  • -ASA class I- III
  • -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

    • Patients with ability to give oral and written informed consent

Exclusion Criteria:

  • Failure to meet the inclusion criteria

    • -Known or suspected neuromuscular disorders impairing neuromuscular function
    • -Allergies to muscle relaxants, anesthetics or narcotics
  • A (family) history of malignant hyperthermia

    • -Women who are or may be pregnant or are currently breast feeding
    • -Contraindications for the use of neostigmine

      • Intestinal obstruction,
      • COPD GOLD 4
    • -Abnormal heart rhythm (eg. bradycardia: < 40/min);
    • -Surgery requiring neuraxial anesthesia / analgesia
    • -Preoperative cognitive dysfunction or mental disabilities
    • -Preexistent significant pulmonary disease with preoperative SpO2 < 90%
    • -Preoperative ICU treatment / intubation (ICU patient);
    • -Need for postoperative ICU treatment or ventilation;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243943


Locations
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Netherlands
Leiden Medical University
Leiden, Zuid Holland, Netherlands, 2333ZA
Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Albert Dahan, MD, PhD, Professor Leiden Medical University

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Responsible Party: Albert Dahan, Prof. Dr. A. Dahan, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02243943     History of Changes
Other Study ID Numbers: NL34186.058.10
NL34186.058.10 ( Other Identifier: LUMC )
First Posted: September 18, 2014    Key Record Dates
Results First Posted: August 25, 2016
Last Update Posted: February 6, 2017
Last Verified: December 2016
Keywords provided by Albert Dahan, Leiden University Medical Center:
Neuromuscular block
neuromuscular reversal
postoperative conditions
respiratory failure
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents