Status:
COMPLETED
Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile
Lead Sponsor:
Leiden University Medical Center
Conditions:
Postoperative Respiratory Condition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 neuromuscul...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02243943
Start Date
September 1 2014
End Date
April 1 2016
Last Update
February 6 2017
Active Locations (1)
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1
Leiden Medical University
Leiden, South Holland, Netherlands, 2333ZA