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OpenTrials
Completed

NCT Number: NCT02243943

Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

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.

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Key information

Conditions

Postoperative Respiratory Condition Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leiden Medical University

Leiden, South Holland, 2333ZA, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Sugammadex

Drug

Other names: Bridion

Neostigmine

Drug

Other names: Prostigmin

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit

Acronym: Neuropa

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2014
Registry last updated
Feb 6, 2017

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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