Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Respiratory Condition

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg | Drug: Sugammadex<br> <br> * Other names: Bridion;|
| Active Comparator: neostigmine<br>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg | Drug: Neostigmine<br> <br> * Other names: Prostigmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Lowest Saturation | 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 | 45 minutes post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | using the 1-10 numeric rating scale | 45 minutes post surgery | 
| Sedation | using the Leiden observer alertness score (1 alert - 5 sedated) | 45 minutes post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular block, neuromuscular reversal, postoperative conditions, respiratory failure