Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit
Overview
- Phase
- Phase 4
- Intervention
- Sugammadex
- Conditions
- Postoperative Respiratory Condition
- Sponsor
- Leiden University Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mean Lowest Saturation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Albert Dahan
Prof. Dr. A. Dahan
Leiden University Medical Center
Eligibility 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
Arms & Interventions
Sugammadex
Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Intervention: Sugammadex
neostigmine
subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Intervention: Neostigmine
Outcomes
Primary Outcomes
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
- Sedation(45 minutes post surgery)
- Pain(45 minutes post surgery)